natgillin/translations-raw huggingface dataset:
• Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig.
3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader inhalatorens mundstykke) på 55 mikrogram umeclidinium (umeclidinium) (svarende til 65 mikrogram umeclidiniumbromid (umeclidinii bromidum)).
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Kontakt straks lægen eller apoteket, hvis du ved et uheld har taget for meget af Rolufta Ellipta, da du kan have brug for lægehjælp.
If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Oversigt over indlægssedlen
Summary of the safety profile
Rolufta Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid)
Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
I studiet af 24 ugers varighed viste Rolufta Ellipta en større forbedring sammenlignet med placebo i ændring i forhold til baseline af den samlede SRGQ-score ved uge 24 (-4,69 enheder, p < 0,001∗).
A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
Marketing Authorisation Holder
Almindelige bivirkninger
Common side effects
Hvis du har taget for meget Rolufta Ellipta
If you use more Rolufta Ellipta than you should
Åndenød:
Breathlessness:
Rolufta Ellipta 55 mikrog inhalationspulver umeclidinium (umeclidiniumbromid)
Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Ikke almindelig
Uncommon
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Amning
Carton
Kasseres senest:
Discard by:
Indlægsseddel: Information til brugeren Rolufta Ellipta 55 mikrogram inhalationspulver, afdelt umeclidinium (umeclidiniumbromid) umeclidinium (umeclidinii bromidum)
Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Multipakning med 3 inhalatorer med hver 30 doser.
Multipack of 3 x 30 dose inhalers.
KOL-eksacerbationer
LIST OF EXCIPIENTS
Rolufta Ellipta 55 mikrog inhalationspulver umeclidinium (umeclidinii bromidum) Til inhalation.
Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide) Inhalation use
Hoste
Excipients
• hoste
• cough
Versus placebo
Vision blurred
Bakken indeholder en pose med tørremiddel for at beskytte mod fugt.
The tray contains a desiccant sachet, to reduce moisture.
Det er ikke nødvendigt at kontrollere, om inhalatoren virker korrekt, før du bruger Rolufta Ellipta første gang.
The first time you use Rolufta Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Sådan skal du tage Rolufta Ellipta
How to use Rolufta Ellipta
1 inhalator med 7 doser 1 inhalator med 30 doser
1 inhaler of 7 doses.
• kløe • udslæt (nældefeber) eller rødme.
• itching • skin rash (hives) or redness
Ikke almindelige bivirkninger
Uncommon side effects
INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
For instructions for handling, see section 4.2.
Datoen for, hvornår inhalatoren skal kasseres, skal angives på etiketten i det dertil beregnede felt.
The “Discard by” date should be written on the inhaler label in the space provided.
• sløret syn
• dry mouth
28 depotplastre (7 x 2 mg/24t, 7 x 4 mg/24t, 7 x 6 mg/24t, 7 x 8 mg/24t)
28 patches (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
Særnavn Styrke Lægemiddelfor m
PE/Alu/ ET copolymer/paper)
Spørgsmål og svar
Questions and answers
Ansøgningen blev trukket tilbage på ‘dag 180'.
The application was withdrawn at ‘day 180'.
Det forventedes anvendt uden recept.
It was expected to be used without prescription.
20. januar 2010 EMA/285622/2010 EMEA/H/C/1108
EMA/23377/2010 EMEA/H/C/1108
Virksomheden fremlagde resultater af tre hovedundersøgelser, hvori der deltog ca. 900 voksne med smerter.
The company presented the results of three main studies involving around 900 adults with pain.
Det skulle have været leveret som kapsler.
It was to be available as capsules.
Sammendrag af ansøgningen på tidspunktet for tilbagetrækningen
Summary of the application at the time of withdrawal
Der forelå heller ikke tilstrækkelig information om lægemidlets sikkerhed i forhold til lægemidler, der kun indeholdt et af de aktive stoffer.
There was also insufficient information on the safety of the medicine compared with medicines containing only one of the active substances.
Hovedundersøgelserne omfattede forholdsvis unge patienter, og der kunne derfor ikke drages nogen konklusioner om, hvordan lægemidlet virkede i andre aldersgrupper.
The main studies involved relatively young patients and therefore no conclusion could be drawn on how the medicine would work in other age groups.
Hvad anbefalede CHMP på daværende tidspunkt?
What was the recommendation of the CHMP at that time?
Det betyder, at CHMP havde evalueret den dokumentation, som virksomheden havde fremlagt, og udarbejdet en liste over spørgsmål.
This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
How far into the evaluation was the application when it was withdrawn?
Hvad er konsekvenserne for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
What are the consequences for patients in clinical trials or compassionate use programmes?
Brevet fra virksomheden, hvori CHMP underrettes om tilbagetrækning af ansøgningen, kan ses her.
The letter from the company notifying the CHMP of the withdrawal of the application is available here.
De primære effektmål var, i hvor høj grad det lindrede smerterne efter to timer, hvor mange patienter der sov efter en time, og hvor længe de sov.
The main measures of effectiveness were based on the level of pain relief after two hours, the number of patients who were asleep after one hour and how long the patients slept.
Dets vigtigste funktion er at blokere histaminreceptorer, som medvirker til at forårsage betændelse og allergiske reaktioner, men det har også en søvndyssende effekt, som hjælper med at forbedre søvnen.
Its main action is to block receptors for histamine, which is involved in inflammation and allergic reactions, but it also leads to drowsiness which helps to improve sleep.
Når de to aktive stoffer blev taget i kombination med hinanden, forventedes de at have gavnlige virkninger for patienter, som har problemer med at sove på grund af smerter.
When taken together, the two active substances were expected to provide benefits for patients with pain who have difficulty sleeping because of the pain.
Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene på listen, var der fortsat visse uafklarede spørgsmål.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
I undersøgelserne blev lægemidlet sammenlignet med placebo (et virkningsløst præparat) og et lægemiddel, der kun indeholdt ibuprofen.
The studies compared the medicine with placebo (a dummy treatment) and a medicine containing ibuprofen alone.
Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
What were the reasons given by the company for withdrawing the application?
Ibuprofen er et smertestillende middel, som tilhører klassen af non-steroide antiinflammatoriske stoffer (NSAID).
Ibuprofen is a painkiller that belongs to the class non-steroidal anti-inflammatory drugs (NSAIDs).
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at ibuprofen/diphenhydraminhydrochlorid Wyeth ikke kunne være blevet godkendt.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ibuprofen/Diphenhydramine Hydrochloride Wyeth could not have been approved.
Diphenhydraminhydrochlorid er et antihistamin.
Diphenhydramine hydrochloride is an antihistamine.
Da det var hensigten, at ibuprofen/diphenhydraminhydrochlorid Wyeth skulle kunne udleveres uden recept, anmodede udvalget om flere oplysninger om, hvordan det interagerede med andre lægemidler.
Because Ibuprofen/Diphenhydramine Hydrochloride Wyeth was intended to be available without a prescription, the Committee requested more information on how it would interact with other medicines.
Det virker ved at blokere et enzym kaldet cyclo-oxygenase, som producerer prostaglandiner.
It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation and pain.
Den 7. januar 2010 meddelte Wyeth Consumer Healthcare officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om ændring af markedsføringstilladelsen for ibuprofen/diphenhydraminhydrochlorid Wyeth til behandling af milde til moderate smerter hos voksne, som har problemer med at sove på grund af smerter.
On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Ibuprofen findes i lægemidler mod smerter, betændelse og feber.
Ibuprofen is found in medicines used to treat pain, inflammation and fever.
Virkningerne af ibuprofen/diphenhydraminhydrochlorid Wyeth blev først undersøgt i forsøgsmodeller, inden det blev undersøgt hos mennesker.
The effects of Ibuprofen/Diphenhydramine Hydrochloride Wyeth were first tested in experimental models before being studied in humans.
Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen?
What documentation did the company present to support its application?
CHMP bemærkede, at ansøgeren ikke havde fremlagt tilstrækkelig dokumentation for, at der var en relevant fordel ved at anvende ibuprofen/diphenhydraminhydrochlorid Wyeth frem for ibuprofen alene.
The CHMP noted that the applicant had not shown enough evidence that there was a relevant advantage of using Ibuprofen/Diphenhydramine Hydrochloride Wyeth over using ibuprofen alone.
Diphenhydraminhydrochlorid findes i lægemidler, der anvendes mod allergier, hoste og søvnproblemer.
Diphenhydramine hydrochloride is found in medicines used to treat allergies, cough and sleep problems.
Ibuprofen/diphenhydraminhydrochlorid Wyeth indeholder to aktive stoffer, som i mange år har været tilgængelige i Den Europæiske Union i almindeligt anvendte lægemidler, der udleveres uden recept.
Ibuprofen/Diphenhydramine Hydrochloride Wyeth contains two active substances that have been available in the European Union for many years in commonly used non-prescription medicines.
Ibuprofen/diphenhydraminhydrochlorid Wyeth forventedes anvendt til kortvarig behandling af milde til moderate smerter hos voksne, som har problemer med at sove på grund af smerter.
Ibuprofen/Diphenhydramine Hydrochloride Wyeth was expected to be used for the short-term treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Ibuprofen/diphenhydraminhydrochlorid Wyeth er et lægemiddel, der indeholder de to aktive stoffer ibuprofen og diphenhydraminhydrochlorid.
Ibuprofen/Diphenhydramine Hydrochloride Wyeth is a medicine that contains the active substances ibuprofen and diphenhydramine hydrochloride.
Virksomheden har oplyst CHMP om, at der på nuværende tidspunkt ikke er nogen igangværende kliniske undersøgelser med eller programmer for anvendelse af ibuprofen/diphenhydraminhydrochlorid Wyeth med særlig udleveringstilladelse.
The company informed the CHMP that at present there are no ongoing clinical trials or compassionate use programmes with Ibuprofen/Diphenhydramine Hydrochloride Wyeth.
Hvad er ibuprofen/diphenhydraminhydrochlorid Wyeth?
What is Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
Hvad forventedes ibuprofen/diphenhydraminhydrochlorid Wyeth anvendt til?
What was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to be used for?
Hvordan forventedes ibuprofen/diphenhydraminhydrochlorid Wyeth at virke?
How was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to work?
Den anbefalede dosis er én tablet én gang dagligt sammen med et måltid.
The recommended dose is one tablet once daily with a meal.
Yderligere information om Juluca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Juluca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Juluca må ikke anvendes sammen med følgende lægemidler, da de kan nedsætte dets virkning:
Juluca must not be used with the following medicines because they may reduce its effectiveness:
Andre oplysninger om Juluca
Other information about Juluca
Det helbreder ikke HIV-infektion eller AIDS, men kan sinke den skade på immunsystemet og udvikling af de infektioner og sygdomme, der er forbundet med AIDS.
It does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Som for alle lægemidler, er data vedrørende brug af Juluca løbende overvåget.
As for all medicines, data on the use of Juluca are continuously monitored.
Da Juluca ikke indeholder et NRTI, er det uden de langsigtede bivirkninger, der forårsages af NRTI.
Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs.
For mere information om brug af Juluca, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Juluca, see the package leaflet or contact your doctor or pharmacist.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Juluca?
What measures are being taken to ensure the safe and effective use of Juluca?
På denne måde hjælper Juluca med at forhindre spredning af HIV-1 og holde mængden af virusset i blodet på et lavt niveau.
In this way, Juluca helps to prevent the spread of HIV-1 and keep the amount of the virus in the blood at a low level.
De alvorligste bivirkninger (som kan forekomme hos op til 1 ud af 100 behandlede), er allergiske reaktioner, herunder udslæt og leverskade.
The most serious side effects (which may affect up to 1 in 100) include allergic reactions that include rash or liver damage.
Juluca (dolutegravir/rilpivirin)
Juluca (dolutegravir / rilpivirine)
Bivirkninger indberettet for Juluca vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.
Det er ikke egnet til patienter, hos hvem ethvert HIV-lægemiddel er holdt op med at virke, eller patienter, som er smittet med HIV, der er resistent over for lægemidler, som virker på samme måde som de aktive indholdsstoffer i Juluca.
It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.
• dexamethason indgivet gennem munden eller ved injektion (et antiinflammatorisk og immunundertrykkende steroidt lægemiddel), undtagen når anvendes som enkeltdosisbehandling
• dexamethasone given by mouth or by injection (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single-dose treatment;
Andelen af patienter med viral belastning under 50 kopier/ml efter 48 uger var den samme for de patienter, der skiftede, som for dem, der fortsatte med de eksisterende lægemidler (95 % i begge tilfælde).
The proportion of patients whose viral load was below 50 copies/ml after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).
Hvorfor er Juluca godkendt i EU?
Why is Juluca authorised in the EU?
En oversigt over Juluca og hvorfor det er godkendt i EU
An overview of Juluca and why it is authorised in the EU
Agenturet afgjorde, at fordelene ved Juluca opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The Agency decided that Juluca's benefits are greater than its risks and it can be authorised for use in the EU.
Undersøgelserne havde deltagelse af i alt 1.028 patienter, hos hvem HIV-infektionen var velkontrolleret i mindst 6 måneder på en kombination af tre HIV-lægemidler, der omfattede en klasse af HIV-lægemidler, der kaldes nukleosid- (eller nukleotid-) reverse transkriptasehæmmere (NRTI).
The studies involved a total of 1,028 patients whose HIV infection was well controlled for at least 6 months on a combination of three HIV medicines that included a class of HIV medicines called nucleoside (or nucleotide) reverse transcriptase inhibitors (NRTIs).
Hvad er Juluca, og hvad anvendes det til?
What is Juluca and what is it used for?
Juluca udleveres kun på recept, og bør ordineres læger med erfaring i behandling af HIV-infektioner.
Juluca can only be obtained with a prescription and it should be prescribed by doctors experienced in managing HIV infection.
Det Europæiske Lægemiddelagentur fandt, at effektiviteten af Juluca var sammenlignelig med kombinationsbehandling med tre HIV-lægemidler, hvori der indgår NRTI.
The European Medicines Agency considered that Juluca's effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs.
Hvilke risici er der forbundet med Juluca?
What are the risks associated with Juluca?
Juluca anvendes kun til patienter, hos hvem mængden af HIV-1 i blodet (deres virale belastning) har været under 50 kopier/ml i mindst 6 måneder på deres nuværende kombinerede HIV-behandling.
Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination.
De hyppigste bivirkninger ved Juluca er diarré og hovedpine.
The most common side effects with Juluca are diarrhoea and headache.
• rifampicin og rifapentin (antibiotika)
• rifampicin, rifapentine (antibiotics);
To hovedundersøgelser viste, at kombinationen af dolutegravir og rilpivirin (de aktive stoffer i Juluca) var effektiv til at holde HIV-infektionen under kontrol.
Two main studies found that the combination of dolutegravir and rilpivirine (the active substances in Juluca) was effective for keeping HIV infection under control.
De to aktive stoffer i Juluca, dolutegravir og rilpivirin, blokerer virkningerne af enzymer, som HIV behøver for at danne kopier af sig selv i de celler, det har smittet.
The two active substances in Juluca, dolutegravir and rilpivirine, block the actions of enzymes that the HIV needs to make copies of itself in the cells it has infected.
• carbamazepin, oxcarbazepin, phenobarbital, phenytoin (lægemidler mod epilepsi)
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
Juluca er et HIV-lægemiddel, der anvendes til behandling af voksne smittet med humant immundefektvirus type 1 (HIV-1), som er årsag til erhvervet immundefektsyndrom (AIDS).
Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Bivirkningerne af Juluca er velkendte og kan behandles.
The side effects of Juluca are well known and manageable.
De aktive indholdsstoffer i Juluca er dolutegravir og rilpivirin.
The active substances in Juluca are dolutegravir and rilpivirine.
Dolutegravir har været godkendt siden 2014, og rilpivirin har været godkendt siden 2011.
Both active substances are already available in the European Union: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.
Undersøgelserne sammenlignede effektiviteten af at skifte til kombinationen af dolutegravir og rilpivirin med at fortsætte med den nuværende kombination af HIVlægemidler.
The studies compared the effectiveness of switching to the combination of dolutegravir and rilpivirine with that of remaining on the current combination of HIV medicines.
Den fuldstændige liste over begrænsninger og bivirkninger med Juluca fremgår af indlægssedlen.
For the full list of restrictions and side effects of Juluca, see the package leaflet.
• perikum (et naturlægemiddel, der anvendes til behandling af depression).
• St John's wort (a herbal medicine used for treating depression).
Hvordan anvendes Juluca?
How is Juluca used?
• omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (syrepumpehæmmere, der nedsætter mavesyreproduktionen)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Hvilke fordele viser studierne, at der er ved Juluca?
What benefits of Juluca have been shown in studies?
Hvordan virker Juluca?
How does Juluca work?
Rilpivirin er en ikke-nukleosid reverse transkriptasehæmmer, dvs. det blokerer aktiviteten af enzymet reverse transkriptase.
Dolutegravir, an integrase inhibitor, blocks an enzyme called integrase while rilpivirine, a non-nucleoside reverse-transcriptase inhibitor, blocks the activity of another enzyme called reverse transcriptase.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Juluca.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Juluca have been included in the summary of product characteristics and the package leaflet.
Dette sammendrag blev sidst ajourført i januar 2015.
This summary was last updated in January 2015.
Dette dokument kan ikke erstatte en personlige drøftelse med din dyrlæge.
This document cannot replace a face-to-face discussion with your veterinarian.
Vaccinen bør ikke håndteres af personer med svagt immunsystem.
The vaccine should not be handled by people with a weak immune system.
Vaccinen gives som to doser, der injiceres under huden.
The vaccine is given as two doses injected under the skin.
De omfattede unge og voksne katte af forskellige racer, men ikke små killinger.
They included young and adult cats of various breeds, but not young kittens.
Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige drøftelse (også en del af denne EPAR).
If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Vaccinen medvirker til at mindske symptomerne på sygdommene.
The vaccine helps to reduce the symptoms of the diseases.
Hvis du ønsker yderligere oplysninger om dit dyrs sygdomstilstand eller behandling, kan du kontakte din dyrlæge.
If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
This is a summary of the European public assessment report.
Den medvirker desuden til at reducere virusudskillelsen i tilfælde af infektion med calicivirus i ét år efter vaccination.
It also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.