FrancophonIA/ELRC3.0 huggingface dataset:
English: if you have recently had an operation on your nose or you have injured your nose.
Danish: • hvis du for nylig er blevet opereret i næsen, eller hvis du har sår eller skader i næsen, skal du vente med at bruge næsesprayen, indtil dette er helet.
English: • The other ingredients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate,
Danish: • Øvrige indholdsstoffer: mikrokrystallinsk cellulose og carmellosenatrium (dispergibel cellulose), glycerol, natriumcitrat, citronsyremonohydrat, polysorbat 80, benzalkoniumchlorid og renset vand.
English: What Nasonex is and what it is used for What you need to know before you use Nasonex How to use Nasonex
Danish: Det skal du vide, før du begynder at bruge Nasonex Sådan skal du bruge Nasonex Bivirkninger
English: The usual dose is two sprays into each nostril once a day.
Danish: Den sædvanlige dosis er 2 pust i hvert næsebor 1 gang dagligt.
English: If you develop any of these effects, you should contact your doctor.
Danish: Kontakt lægen, hvis du udvikler nogle af disse symptomer.
English: How to use Nasonex
Danish: SÅDAN SKAL DU BRUGE NASONEX
English: [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: [Se bilag I - Udfyldes nationalt] mometasonfuroat
English: Treatment with NASONEX Nasal Spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.
Danish: Hos patienter, som tidligere har haft moderate til svære symptomer på sæsonbetinget allergisk rhinitis, kan det være nødvendigt at initiere behandling med Nasonex næsespray nogle dage før pollensæsonen forventes at starte.
English: swollen face, tongue or pharynx trouble swallowing hives wheezing or trouble breathing
Danish: • hævelse af ansigt, tunge eller svælg
English: How to use your nasal spray
Danish: Sådan anvendes næsesprayen
English: increase in pressure in the eye (glaucoma) and/or cataracts causing visual disturbances, damage to the partition in the nose which separates the nostrils changes in taste and smell difficulty in breathing and/or wheezing
Danish: • forhøjet tryk i øjet (glaukom) og/eller grå stær (katarakt), som kan medføre synsforstyrrelser
English: Nasal Spray, Suspension.
Danish: Nasonex er en næsespray, suspension.
English: Lactation
Danish: Natriumcitrat
English: There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with NASONEX Nasal Spray.
Danish: Efter langvarig behandling med Nasonex næsespray er der ikke tegn på suppression af hypothalamushypofyse-binyrebarkaksen.
English: Pharyngitis
Danish: Dosering
English: PACKAGE LEAFLET
Danish: mometasonfuroat
English: Tell your doctor if you accidentally use more than you were told.
Danish: Hvis du har brugt for meget Nasonex Fortæl lægen, hvis du ved et uheld har taget mere end foreskrevet.
English: Cataracts
Danish: Katarakt
English: It has been used in medicines for several decades.
Danish: Det har været anvendt i lægemidler i adskillige årtier.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Plenadren on 3 November 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Plenadren den 3. november 2011.
English: Other information about Plenadren
Danish: Andre oplysninger om Plenadren
English: It is available as modified-release tablets (5 mg and 20 mg).
Danish: Det fås som tabletter med modificeret udløsning (5 mg og 20 mg).
English: Plenadren hydrocortisone
Danish: Plenadren hydrocortison
English: This is a summary of the European public assessment report (EPAR) for Plenadren.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Plenadren.
English: In situations of excessive physical or mental stress or illness, patients may need further doses of hydrocortisone.
Danish: I situationer med overdreven psykisk eller mental stress eller sygdom kan patienten have brug for yderligere doser af hydrocortison.
English: Why is Plenadren approved?
Danish: Hvorfor blev Plenadren godkendt?
English: The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Plenadren opvejede risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: What measures are being taken to ensure the safe and effective use of Plenadren?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Plenadren?
English: It is not intended to provide practical advice on how to use Plenadren.
Danish: Det er ikke en praktisk vejledning i, hvordan Plenadren bør anvendes.
English: Symptoms include weight loss, muscle weakness, fatigue, low blood pressure, and sometimes darkening of the skin.
Danish: Symptomerne omfatter vægttab, muskelsvækkelse, træthed, lavt blodtryk og nogle gange mørkfarvning af huden.
English: What is Plenadren and what is it used for?
Danish: Hvad er Plenadren, og hvad anvendes det til?
English: This may be given as Plenadren tablets twice or three times daily or as conventional immediate-release tablets or injections, either alone or in combination with Plenadren.
Danish: Plenadren-tabletter to eller tre gange dagligt eller i form af konventionelle tabletter med umiddelbar udløsning eller injektioner, enten alene eller i kombination med Plenadren.
English: Plenadren can only be obtained with a prescription.
Danish: Plenadren udleveres kun efter recept.
English: Because the number of patients with adrenal insufficiency is low, the disease is considered ‘rare', and Plenadren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Danish: Da der kun findes få patienter med binyreinsufficiens, betragtes sygdommen som "sjælden", og Plenadren blev udpeget som et "lægemiddel til sjældne sygdomme" den 22. maj 2006.
English: The effects of Plenadren were investigated in one main study involving 64 patients with adrenal insufficiency.
Danish: Virkningerne af Plenadren blev undersøgt i én hovedundersøgelse med deltagelse af 64 patienter med binyreinsufficiens.
English: Although once daily dosing comes with a risk of cortisol levels being too low in the afternoon, this can be managed by adding further doses of hydrocortisone if needed.
Danish: Selv om et doseringsregime på én daglig dosis indebærer en risiko for, at cortisolniveauerne er for lave om eftermiddagen, kan dette håndteres ved at tilføje yderligere doser af hydrocortison om nødvendigt.
English: Adrenal insufficiency (including primary insufficiency or Addison's disease) is a condition where the adrenal glands (located just above the kidneys) do not produce enough of a steroid hormone called cortisol (also known as the stress hormone because it is released in response to stress).
Danish: Binyreinsufficiens (herunder primær binyreinsufficiens eller Addisons sygdom) er en tilstand, hvor binyrerne (lige over nyrerne) ikke producerer nok af et steroidt hormon kaldet cortisol (også kaldet stresshormonet, fordi det udløses som reaktion på stress).
English: The full EPAR for Plenadren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Plenadren findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What are the risks associated with Plenadren?
Danish: Hvilke risici er der forbundet med Plenadren?
English: Adrenal insufficiency can require life-long treatment to replace the missing cortisol.
Danish: Binyreinsufficiens kan kræve livslang behandling for at erstatte det manglende cortisol.
English: The study looked at the levels of cortisol in the patients' blood during a 24-hour period following three months of treatment.
Danish: I undersøgelsen så man på cortisolindholdet i patienternes blod over en periode på 24 timer efter tre måneders behandling.
English: Plenadren, given once per day, was compared with conventional hydrocortisone treatment, which is given three times per day.
Danish: Plenadren givet én gang dagligt blev sammenlignet med en traditionel behandling med hydrocortison, der gives tre gange dagligt.
English: The most common side effects with Plenadren (seen in more than 1 patient in 10) are fatigue (tiredness), diarrhoea, vertigo (feeling dizzy) and headache.
Danish: De hyppigste bivirkninger ved Plenadren (som optræder hos flere end 1 ud af 10 patienter) er træthed, diarré, svimmelhed og hovedpine.
English: For more information about treatment with Plenadren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Plenadren, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Plenadren contains the active substance hydrocortisone.
Danish: Plenadren indeholder det aktive stof hydrocortison.
English: Treatment may need to be individually adjusted according to how the patient responds.
Danish: Afhængigt af den enkelte patients respons kan det være nødvendigt at tilpasse dosen.
English: It is taken early in the morning to mimic the fact that in healthy people the blood level of cortisol increases early in the morning.
Danish: Det tages tidligt om morgenen for at efterligne tilstanden hos en rask person, hvor mængden af cortisol i blodet normalt stiger om morgenen.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Plenadren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Plenadren findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at Plenadren tilvejebragte tilfredsstillende cortisolniveauer under behandlingen af patienter med binyreinsufficiens.
English: The overall amount of cortisol absorbed into the blood was around 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatment.
Danish: Den overordnede mængde cortisol optaget i blodet var ca. 20 % lavere hos patienter, der tog Plenadren, sammenlignet med patienter, der fik en traditionel behandling med hydrocortison.
English: For the full list of all side effects and restrictions with Plenadren, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Plenadren fremgår af indlægssedlen.
English: Plenadren is a medicine used to treat adrenal insufficiency in adults.
Danish: Plenadren er et lægemiddel, der anvendes til behandling af binyreinsufficiens hos voksne.
English: Hydrocortisone replaces the natural cortisol that is missing in patients with adrenal insufficiency.
Danish: Hydrocortison erstatter den naturlige cortisol, der mangler hos patienter med binyreinsufficiens.
English: The active substance in Plenadren, hydrocortisone, is the pharmaceutical form of cortisol, the main steroid hormone secreted by the adrenal gland.
Danish: Det aktive stof i Plenadren, hydrocortison, er lægemiddelformen af cortisol, som er det vigtigste steroide hormon, der dannes i binyren.
English: In patients taking Plenadren the cortisol levels achieved were considered to be satisfactory for patients with adrenal insufficiency.
Danish: Hos patienter, der tager Plenadren, ansås de opnåede cortisolniveauer for at være tilfredsstillende for patienter med binyreinsufficiens.
English: What benefits of Plenadren have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Plenadren?
English: The Committee also noted that with Plenadren there is the convenience of once daily dosing.
Danish: Udvalget bemærkede også, at Plenadren har fordelen af et doseringsregime på én daglig dosis.
English: For practical information about using Plenadren, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Plenadren, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because it is available as a modified-release tablet, Plenadren releases hydrocortisone over a longer period of time allowing for a once-daily dosing.
Danish: Eftersom det fås som en tablet med modificeret udløsning, danner Plenadren hydrocortison over en længere periode og giver mulighed for et doseringsregime på én daglig dosis.
English: How is Plenadren used?
Danish: Hvordan anvendes Plenadren?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Plenadren have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Plenadren.
English: The usual daily dose ranges from 20 to 30 mg, once per day early in the morning; tablets should be swallowed whole with a glass of water at least 30 minutes before food.
Danish: Den sædvanlige daglige dosis er 20-30 mg én gang pr. dag tidligt om morgenen.
English: How does Plenadren work?
Danish: Hvordan virker Plenadren?
English: Ristfor is taken twice a day.
Danish: Ristfor tages to gange dagligt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ristfor on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ristfor den 15.marts 2010.
English: Other information about Ristfor:
Danish: Andre oplysninger om Ristfor:
English: Metformin has been available in the EU since the 1950s.
Danish: Metformin har været godkendt i EU siden 1950'erne.
English: It is used in addition to diet and exercise in the following ways:
Danish: Der anvendes i forbindelse med diæt og motion på følgende måder:
English: This document is a summary of the European Public Assessment Report (EPAR) for Ristfor.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ristfor.
English: This authorisation was based on the authorisation granted to Janumet in 2008 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Janumet i 2008 (‘informeret samtykke').
English: The full EPAR for Ristfor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ristfor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007 and as Tesavel since 2008.
Danish: Sitagliptin har været godkendt i Den Europæiske Union (EU) som Januvia og Xelevia siden 2007 og som Tesavel siden 2008.
English: A risk management plan has been developed to ensure that Ristfor is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ristfor anvendes så sikkert som muligt.
English: The company carried out additional studies to show that the active substances in Ristfor are absorbed by the body in the same way as the two medicines given separately.
Danish: Virksomheden gennemførte yderligere undersøgelser for at vise, at det aktive stof i Ristfor optages i kroppen på samme måde som de to lægemidler givet hver for sig.
English: Ristfor was more effective than metformin alone.
Danish: Ristfor var mere effektivt end metformin alene.
English: What measures are being taken to ensure the safe and effective use of Ristfor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ristfor?
English: Ristfor sitagliptin / metformin hydrochloride
Danish: Ristfor sitagliptin/metforminhydrochlorid
English: The results of three further studies were used to support the use of Ristfor.
Danish: Der blev fremlagt resultater af tre yderligere undersøgelser til støtte for brugen af Ristfor.
English: The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking before.
Danish: Den tabletstyrke, der skal anvendes, afhænger af den dosis af andre lægemidler mod sukkersyge, som patienten fik før.
English: What is the risk associated with Ristfor?
Danish: Hvilken risiko er der forbundet med Ristfor?
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 Ristfor.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ristfor skal anvendes.
English: For more information about treatment with Ristfor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ristfor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Ristfor in patients who were not satisfactorily controlled on their existing metformin treatment.
Danish: Virksomheden fremlagde resultaterne af tre undersøgelser af Januvia/Xelevia til støtte for brugen af Ristfor til patienter, som ikke kunne kontrolleres tilfredsstillende med den nuværende metforminbehandling.
English: Why has Ristfor been approved?
Danish: Hvorfor blev Ristfor godkendt?
English: Sitagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Danish: Sitagliptin er en dipeptidylpeptidase-4 (DPP-4)-hæmmer.
English: It is available as tablets (50 mg sitagliptin and 850 mg metformin hydrochloride; 50 mg sitagliptin and 1,000 mg metformin hydrochloride).
Danish: Det fås som tabletter (50 mg sitagliptin og 850 mg metforminhydrochlorid, 50 mg sitagliptin og 1 000 mg metforminhydrochlorid).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristfor, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Ristfor, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Danish: Det virker ved at blokere kroppens nedbrydning af "inkretin"-hormoner.
English: In the first of the three further studies, Ristfor was more effective than metformin or sitagliptin alone.
Danish: I den første af tre yderligere undersøgelser var Ristfor mere effektivt end metformin eller sitagliptin alene.
English: Serious side effects reported with Ristfor include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Danish: Alvorlige indberettede bivirkninger ved Ristfor omfatter pankreatitis (betændelse i bugspytkirtlen) og overfølsomhed (allergiske reaktioner).
English: Ristfor must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Danish: Ristfor må ikke anvendes til patienter, som har diabetisk ketoacidose eller prækoma (alvorlig tilstand, der kan opstå hos sukkersygepatienter), nyre- eller leverproblemer, sygdomme, som kan påvirke nyrerne, eller en sygdom, som medfører dårlig iltforsyning til vævene, såsom hjerte- eller lungeinsufficiens eller et nyligt hjerteanfald.
English: The CHMP decided that Ristfor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ristfor opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Ristfor.
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 13.8% of patients and with insulin in 10.9% of patients.
Danish: Hypoglykæmi blev indberettet i kombination med et sulfonylurinstof hos 13,8 % af patienterne og hos 10,9 % af patienterne.
English: If Ristfor is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Ristfor tages sammen med et sulfonylurinstof eller insulin, skal dosen af sulfonylurinstof eller insulin muligvis sænkes for at undgå hypoglykæmi (lavt blodsukkerniveau).
English: What is Ristfor?
Danish: Hvad er Ristfor?
English: Ristfor is a diabetes medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Danish: Ristfor er et lægemiddel mod sukkersyge, som indeholder de to aktive stoffer sitagliptin og metforminhydrochlorid.
English: Ristfor should be taken with food to avoid any stomach problems caused by metformin.
Danish: Ristfor skal tages sammen med mad for at undgå, at metformin giver maveproblemer.
English: The active substances in Ristfor, sitagliptin and metformin hydrochloride, each have a different mode of action.
Danish: De aktive stoffer i Ristfor, sitagliptin og metforminhydrochlorid, virker på hver sin måde.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Ristfor with that of metformin or sitagliptin alone.
Danish: Den første undersøgelse omfattede 1 091 patienter, som ikke kunne kontrolleres tilstrækkeligt med diæt og motion alene, og sammenlignede virkningen af Ristfor med virkningen af metformin eller sitagliptin alene.
English: Ristfor is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Ristfor anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodsukkeret (blodets indhold af glukose).
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Danish: • til patienter, som ikke kan kontrolleres tilfredsstillende med metformin (et middel mod sukkersyge)
English: What benefit has Ristfor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ristfor?
English: For the full list of all side effects reported with Ristfor, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Ristfor fremgår af indlægssedlen.
English: How has Ristfor been studied?
Danish: Hvordan blev Ristfor undersøgt?
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: Metformin virker hovedsagelig ved at hæmme produktionen af glukose (sukker) og mindske glukoseoptagelsen fra tarmen.
English: As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og giver dermed bedre kontrol over type 2sukkersyge.
English: What is Ristfor used for?
Danish: Hvad anvendes Ristfor til?
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Danish: Inkretiner er hormoner, der frigives efter et måltid og får bugspytkirtlen til at producere insulin.