natgillin/translations-raw huggingface dataset:
Lenalidomide Celgene Europe forventedes anvendt til behandling af anæmi (lavt antal røde blodlegemer) forårsaget af myelodysplastisk syndrom (en tilstand, hvor knoglemarven ikke kan producere nok blodceller).
Lenalidomide Celgene Europe was expected to be used to treat anaemia (low red blood cell counts) caused by myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Hvad forventedes Lenalidomide Celgene Europe anvendt til?
What was Lenalidomide Celgene Europe expected to be used for?
Hvordan forventes Lenalidomide Celgene Europe at virke?
How is Lenalidomide Celgene Europe expected to work?
--1 Levende attenueret parvovirus fra moskusand ≥ 2.6 log10 CCID50 *
--1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50%
Indhold Paknings størrelse
Packaging Content Package size
10 poser + 10 trokarer
10 bags + 10 trocars
1 pose + 1 trokarer
1 bag + 1 trocar
EU (MA) Nummer Særnavn Styrke Lægemiddelform Dyrearter som lægemidlet er beregnet til
Strength Pharmaceutical form
Dette sammendrag blev sidst ajourført 12-2016.
This summary was last updated in 12-2016.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Relistor den 2. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008.
Disse bivirkninger er sædvanligvis lette eller moderate.
These side effects are generally mild or moderate.
Procentdelen af vellykkede injektioner i de to grupper var henholdsvis ca. 30 % og 9 %.
The percentages of successful injections for the two groups were around 30% and 9%, respectively.
Dosen afhænger af patientens kropsvægt.
The dose depends on the patient's body weight.
Den fuldstændige EPAR for Relistor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Relistor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Relistor.
This is a summary of the European public assessment report (EPAR) for Relistor.
Andre oplysninger om Relistor
Other information about Relistor
Det betyder, at det blokerer en særlig type opioidreceptor kaldet "mu-opioid-receptoren".
This means that it blocks a specific type of opioid receptor called the ‘mu-opioid receptor'.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Relistor opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Agency's Committee for Medicinal Products for Human Use decided that Relistor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Relistor?
What measures are being taken to ensure the safe and effective use of Relistor?
Dosen af Relistor bør nedsættes for patienter med svære nyreproblemer.
The dose of Relistor should be reduced in patients who have severe kidney problems.
Relistor methylnaltrexonbromid
Relistor methylnaltrexone bromide
Hvad er Relistor, og hvad anvendes det til?
What is Relistor and what is it used for?
Relistor udleveres kun efter recept.
Relistor can only be obtained with a prescription.
Hvis du ønsker yderligere oplysninger om behandling med Relistor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Relistor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Relistor er blevet sammenlignet med placebo i en tredje undersøgelse omfattende 496 patienter med forstoppelse forårsaget af opioider, men uden fremskreden sygdom.
Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness.
Hvorfor blev Relistor godkendt?
Why is Relistor approved?
Det er ikke en praktisk vejledning i, hvordan Relistor bør anvendes.
It is not intended to provide practical advice on how to use Relistor.
De hyppigste bivirkninger ved Relistor (som optræder hos flere end 1 ud af 10 patienter) er mavesmerter, kvalme, diarré og flatulens.
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence.
Relistor injiceres normalt under huden på lårene, maven eller overarmene.
Relistor is usually injected under the skin of the upper legs, belly or upper arms.
Relistor anbefales ikke til patienter med meget svær nyresygdom, som kræver dialyse (en blodrensningsteknik).
Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Relistor anvendes til behandling af forstoppelse forårsaget af opioide smertestillende midler (såsom morfin), når afføringsmidler ikke er tilstrækkelige.
Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough.
Methylnaltrexonbromid fremstilles af naltrexon, som er et velkendt stof, der anvendes til at blokere virkningen af opioider.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Ved at blokere disse receptorer, reducerer Relistor forstoppelse, som skyldes opioider, uden at hindre midlets smertestillende virkning.
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Relistor må heller ikke anvendes hos patienter, hvis tarme er blokerede, som risikerer gentagne blokeringer af tarmene, eller som lider af en sygdom, der kræver øjeblikkelig tarmoperation.
Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery.
Hvilke risici er der forbundet med Relistor?
What are the risks associated with Relistor?
Det aktive stof i Relistor, methylnaltrexonbromid, er en "mu-opioid-receptorantagonist".
The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Opioider lindrer smerte ved at binde sig til "opioidreceptorerne" i hjernen og rygmarven.
Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Hvis du ønsker praktisk vejledning om anvendelsen af Relistor, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist.
Det er sværere for methylnaltrexonbromid at få adgang til hjernen, end det er for naltrexon, hvilket betyder, at det blokerer mu-opioid-receptorerne i mave-tarm-kanalen, men ikke i hjernen.
Methylnaltrexone bromide is less able to enter the brain than naltrexone, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
Relistor indeholder det aktive stof methylnaltrexonbromid.
Relistor contains the active substance methylnaltrexone bromide.
Til patienter, der ikke modtager palliativ behandling, gives Relistor som en injektion under huden i en dosis på 12 mg én gang om dagen i mindst 4 dage pr. uge og højst 7 dage pr. uge efter behov.
In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor.
Den fuldstændige liste over indberettede bivirkninger ved Relistor fremgår af indlægssedlen.
For the full list of all side effects reported with Relistor, see the package leaflet.
I den anden undersøgelse så man også på antallet af patienter med udtømning af tarmene mindst to gange inden for fire timer efter de første fire doseringer.
The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses.
Resultaterne viste, at 34 % af de patienter, der fik Relistor (102 out of 298), opnåede udtømning af tarmene inden for fire timer efter den første injektion sammenlignet med 10 % af de patienter, der modtog placebo (16 ud af 162).
Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Når opioider binder sig til mave-tarm-kanalens receptorer, reduceres mave-tarm-kanalens mobilitet, hvilket medfører forstoppelse.
When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation.
Hovedeffektmålet var antallet af patienter med udtømning af tarmene inden for fire timer efter den første dosis og procentdelen af injektioner, som medførte udtømning af tarmene.
The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Relistor.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relistor have been included in the summary of product characteristics and the package leaflet.
I den anden undersøgelse opnåede 52 % af de patienter, der fik Relistor, udtømning af tarmene mindst to gange inden for de første fire timer efter de første fire doser (32 ud af 62), sammenlignet med 8 % af de patienter, der fik placebo (6 ud af 71).
In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Hvordan anvendes Relistor?
How is Relistor used?
Af de to undersøgelsers sammenlagte resultater fremgik det, at 55 % af de patienter, der fik Relistor, opnåede udtømning af tarmene inden for fire timer efter den første dosis (91 ud af 165), sammenlignet med 15 % af de patienter, der fik placebo (18 ud af 123).
Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
I begge undersøgelser var hovedeffektmålet antallet af patienter med udtømning af tarmene inden for fire timer efter den første dosis.
The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose.
Når patienterne har fået tilstrækkelig undervisning, kan de selv begynde at foretage injektionen.
Patients can inject Relistor themselves once they have been trained appropriately.
Hvilke fordele viser undersøgelserne, at der er ved Relistor?
What benefits of Relistor have been shown in studies?
Det fås som en injektionsvæske, opløsning, i hætteglas eller i fyldte injektionssprøjter.
It is available as a solution for injection in vials or in prefilled syringes.
Hvordan virker Relistor?
How does Relistor work?
Disse receptorer findes også i mave-tarm-kanalen.
These receptors are also found in the gut.
I to hovedundersøgelser, som omfattede i alt 288 patienter med fremskreden sygdom og forstoppelse forårsaget af opioider, viste Relistor sig at være mere effektivt end placebo (en virkningsløs behandling) til at stimulere tarmmotorikken.
Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Det gives som en injektion under huden én gang hver anden dag ud over de sædvanlige afføringsmidler.
In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
Indehaveren af markedsføringstilladelsen skal blive enig med de nationale kompetente myndigheder om indholdet af undervisningsprogrammet og skal implementere sådan et program nationalt for at sikre, at alle læger får en informationspakke til sundhedspersonale før receptudskrivelse indeholdende det følgende:
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
• Information om erkendte og potentielle risici
• Information on the identified and potential risks.
• Produktresumé (SPC) og indlægsseddel og mærkning
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Medlemslandene skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse beskrevet nedenfor bliver implementeret:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Vigtige elementer at have i uddannelsesmaterialet
Key elements to be included in the educational material
• Information om geldannelse og mulige reaktioner ved injektionsstedet
• Information on gel depot formation and possible injections site reactions
• Uddannelsesmateriale
• Educational material
• Instruktioner for anvendelse
• Instructions for administration
• Dosering
• Posology
De berørte medlemsstater var Tyskland, Ungarn, Norge, Polen, Slovakiet, Spanien og Det Forenede Kongerige.
The Reference Member States were Germany, Hungary, Norway, Poland, Slovakia, Spain, United Kingdom.
CHMP udnævnte dr. J.F.F.
The CHMP appointed Dr. J.F.F.
1 Artikel 29, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
1 Article 29(2) of Directive 2001/83/EC, as amended.
En positiv udtalelse blev vedtaget den 28. juni 2006.
A positive opinion was adopted 28 June 2006.
Disse medlemsstater har ikke kunnet nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Den gensidige anerkendelsesprocedure indledtes den 21. oktober 2005.
The Mutual Recognition Procedure started on 21 October 2005.
Lekkerkerker (Nederlandene) til rapportør og dr. Hudson (Det Forenede Kongerige) til medrapportør.
Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur.
Danmark fremsendte begrundelserne for uenighederne til EMEA den 31. marts 2006.
The Denmark referred the reasons for disagreement to the EMEA on 31 March 2006.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den
The final opinion was converted into a Decision by the European Commission on 11/10/2006.
Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Voldgiftsproceduren indledtes den 27. april 2006.
The arbitration procedure started on 27 April 2006.
Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 23. maj 2006.
Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006.
Winthrop Pharmaceuticals UK Ltd indgav ansøgninger om gensidig anerkendelse af Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne på grundlag af den markedsføringstilladelse, Danmark udstedte den 30. september 2002.
Winthrop Pharmaceuticals UK Ltd submitted applications for mutual recognition of Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Formålet med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxazosin “Winthrop” 4 mg depottabletter afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom svimmelhed og hypotension, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995 og hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer.
The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne (doxazosin) er et alfa-1-receptorblokerende stof, som anvendes til behandling af patienter med essentiel hypertension og til symptomatisk behandling af benign prostatahyperplasi.
Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (Doxazosin) is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Indehaveren af markedsføringstilladelsen afgav mundtlige redegørelser den 27. juni 2006.
Oral explanations were given by the Marketing Authorisation Holder on 27 June 2006.
I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i juni 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Doxazosin “Winthrop” 4 mg depottabletter og tilknyttede navne Internationalt fællesnavn ( INN): Doxazosin
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Studiet skal udføres på baggrund af en aftalt protokol.
The study should be based on an agreed protocol.
- Lad området tørre i 15 minutter.
- Allow the area to dry for 15 minutes.
Frekvenserne er defineret i henhold til følgende konvention:
Frequencies have been defined according to the following convention:
Dato for første markedsføringstilladelse: 15. november 2012 Dato for seneste fornyelse: 13. juli 2017
Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Hos kaniner var der ingen større abnormiteter.
In rabbits there were no major abnormalities.
Vejledning til brug: - Åbn en ny tube hver gang du bruger denne medicin.
Instructions for use: - Open a new tube each time you use this medicine.
Ingen generelle forskelle i sikkerhed eller effekt blev observeret mellem yngre og ældre patienter.
No overall differences in safety or efficacy were observed between younger and older patients.
Patienterne blev fulgt hver 3. måned i 12 måneder (se tabel 5).
Patients were followed every 3 months for 12 months (see table 5).
Nekrose i dermis blev sjældent observeret.
Necrosis in the dermis was rarely observed.
Compliance var høj, idet 98% af patienterne fuldførte studierne.
The compliance rate was high, with 98% of the patients completing these studies.
- Slug ikke denne medicin.
- Do not swallow this medicine.
- Påfør ikke mere gel end hvad lægen har tilrådet.
- Do not apply more gel than your doctor has advised.
Den endelige studierapport skal indsendes:
The final study report shall be submitted:
- Få ikke Picato i øjnene.
- Do not get Picato in your eyes.
8 uger efter randomisering
8 weeks after randomisation
Denne bivirkning er ikke almindelig.
This side effect is uncommon.
Erfaring med behandling af et større område
Experience with treatment of a larger area
Resultatet viste ingen systemisk absorption.
Results demonstrated no systemic absorption.
Immunokompromitterede patienter
Immunocompromised patients
Virkningsgraden varierede mellem de individuelle anatomiske lokaliteter.
The level of efficacy varied between the individual anatomical locations.
Picato må ikke indtages.
Picato must not be ingested.
Behandling af overdosis bør bestå af behandling af kliniske symptomer.
Management of overdose should consist of treatment of clinical symptoms.
Klar farveløs gel.
Clear colourless gel.
Efter denne periode, kan behandlingsområdet vaskes med mild sæbe og vand.
After this period, the treatment area may be washed using mild soap and water.
Du bør undgå brugen af Picato hvis du er gravid.
You should avoid the use of Picato if you are pregnant.
For behandling af halsen:
For treatment of the neck:
- Undgå sollys så meget som muligt (herunder sollamper og solarier).
- Avoid sunlight as much as possible (including sunlamps and tanning beds).
gel 2 tuber
gel 2 tubes
Erfaring med mere end én behandling
Experience with more than one treatment course
Pas på ikke at overføre gel fra behandlingsområdet til dine øjne.
Take care not to transfer gel from the treatment area into your eyes.
Ved 12 måneder var raten for fuldstændig heling i disse grupper henholdsvis 31% og 19%.
At 12 months, the complete clearance rates in these groups were 31% and 19% respectively.
Vask området med vand og sæbe.
Wash the area with soap and water.
d p<0.001; sammenlignet med vehikel ved logistisk regression med behandling, studie og anatomisk placering.
d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location.
Aktinisk keratose forekommer ikke hos børn, og denne medicin må ikke anvendes til børn og teenagere under 18 år.
Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.
gel 3 tuber
gel 3 tubes
- Tryk gel fra én tube ud på en fingerspids.
- Squeeze the gel from one tube onto a fingertip.
Resultatet af den randomiserede og blindede 2. behandling er præsenteret i tabel 6.
The results of the randomised and blinded second treatment course are presented in table 6.
Der er ingen data fra anvendelse af ingenolmebutat til gravide kvinder.
There are no data from the use of ingenol mebutate in pregnant women.
Bivirkningerne kan blive værre i op til 1 uge efter du er stoppet med at bruge dette lægemiddel.
The side effects may get worse for up to 1 week after you have stopped using this medicine.
Opsøg straks lægehjælp, hvis du oplever allergisk reaktion, som kan medføre hævelse af mund, tunge eller hals, når du bruge dette lægemiddel.
Seek medical attention right away if you experience an allergic reaction that may include swelling of the mouth, tongue or throat when using this medicine.
Hvis du tidligere har brugt Picato eller anden lignende medicin fortæl det til lægen, før du begynder behandlingen.
If you have previously used Picato or other similar medicines tell your doctor before starting the treatment.