natgillin/translations-raw huggingface dataset:
- Mercaptopurin (anvendes til behandling af kræft) - Azathioprin (anvendes til at hæmme immunsystemet) - Theophyllin (anvendes til behandling af astma) 
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Krka and your doctor may wish to consider necessary measures: - Mercaptopurine (used to treat cancer) - Azathioprine (used to reduce immune response) - Theophylline (used to treat asthma)
Det skal du vide, før du begynder at tage Febuxosat Krka Sådan skal du tage Febuxosat Krka Bivirkninger 
What Febuxostat Krka is and what it is used for What you need to know before you take Febuxostat Krka How to take Febuxostat Krka Possible side effects
Forhøjet blodglucose, forlænget aktiveret partiel tromboplastintid, nedsat erytrocyttal, forhøjet basisk phosphatase, forhøjet kreatinphosphokinase i blodet* 
Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
(leukocytose med eller uden eosinofili) - rødme af huden (erytem), forskellige former for udslæt (f.eks. kløende, med hvide pletter, med blærer, med betændte blærer, med afskalning eller mæslingelignende), udbredt rødme af huden, 
(hemorrhage, seen only in patients taking chemotherapy for blood disorders) - cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis - dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort - itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin,
Som konklusion kan CHMP tilslutte sig, at den af ansøgeren forelagte besvarelse viser, at spørgsmålene er afklaret. 
In conclusion, the CHMP agrees that the responses submitted by the Applicant indicate that the issues are resolved.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VANTAS (se bilag I) 
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VANTAS (see Annex I)
Indehaver af markedsføringstilladelse 
Marketing Authorisation Holder Applicant
Intet tyder på, at medlemmerne af klassen afviger indbyrdes med hensyn til virkning og sikkerhed, og Vantas synes ikke at danne en undtagelse i denne henseende. 
There is no indication that any of the members within this class differs with respect to efficacy and safety, and Vantas seems to be no exception in that respect.
Den lokale sikkerhed af Vantas er tilstrækkelig undersøgt, og yderligere sammenlignende undersøgelser er ikke nødvendige. 
The local safety of Vantas is sufficiently investigated and further comparative studies are not necessary.
Der må skelnes mellem sikkerhedsaspekterne af antiandrogen behandling generelt og den (lokale) sikkerhed af det aktuelle produkt. 
A distinction should be made between safety aspects of androgen suppression therapy in general and the (local) safety of this product.
25-28 North Wall Quay, Dublin, Irland 
Denmark Valera Pharmaceuticals Ireland Ltd. 25-28 North Wall Quay, Dublin, Ireland
Med en virkning på 98-100 % i reduktion af serum-testosteron er yderligere undersøgelser med aktivt sammenligningspræparat overflødige. 
With an efficacy of 98-100% in serum testosterone reduction further active comparator studies are redundant and thus not necessary.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE 
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Sikkerhedsdatabasen forekommer begrænset, men hverken i den amerikanske overvågning efter markedsføring eller i de kliniske undersøgelser er der forekommet uventede sikkerhedsproblemer. 
The safety database seems limited, but no unexpected safety issues have occurred nor in the American post marketing surveillance neither in the trials.
Sikkerheden af antiandrogen behandling er veldokumenteret, og yderligere oplysninger er ikke nødvendige for dette produkt. 
The safety of androgen suppression is well known and further information is not necessary for this product.
Antiandrogen behandling betragtes som palliativ. 
Androgen ablation is considered to be a palliative treatment.
Tidligere opnåedes suppression af testosteron ved bilateral orkietomi (kirurgisk kastration). 
In the past, testosterone suppression was achieved by bilateral orchiectomy (surgical castration).
Forslaget fra ansøgeren/indehaveren af markedsføringstilladelsen om at medtage fem sikkerhedshensyn i risikostyringsplanen kan godtages (heraf vedrører de to specielt formuleringen af Vantas, mens de andre tre kan klassificeres som klassevirkninger: afstødning, cellulitis, rødme, osteoporose og forlænget QT-interval). 
The proposal of the applicant/MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed (two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation).
Det niveau af serum-testosteron, der svarer til kastration, er sædvanligvis blevet sat til under 50 ng/dl (1,7 nmol/l), idet der tages højde for den kendte målevariation på referencelaboratorier. 
Serum testosterone concentrations that correspond to castration levels have generally been set at less than 50 ng/dL (1.7 nmol/L), given the known variability of values in reference laboratories.
I princippet er det vigtigt at opnå så lav serumtestosteron som muligt, så den antiandrogene behandling minimerer stimulationen af prostatacancerceller. 
In principle, it is important to achieve serum testosterone concentrations as low as possible for ADT to minimize stimulation of prostate cancer cells.
Der kunne have været anvendt en anden GnRH-analog, hvilket dog er overflødigt på baggrund af den af ansøgeren fremlagte metaanalyse; orkiektomi er uacceptabel, når reversible metoder foreligger, diethylstilbestrol er obsolet, og nonsteroide antiandrogener kan have ringere virkning anvendt som monoterapi. 
Another LHRH agonist could be used, but this is superfluous considering the meta-analysis presented by Applicant, orchidectomy is not acceptable when reversible methods are available, DES is obsolete and non-steroidal anti-androgens may have inferior efficacy when used as monotherapy.
Data fra langtidsforlængelsen af undersøgelse 301 underbygger den langsigtede sikkerhed ved behandling med Vantas i to år eller længere. 
The data of the Long Term Extension of Study 301 support long-term safety for patients treated with Vantas for two or more years.
Vantas er en ny GnRH-analog tilhørende en farmakologisk klasse, der er indført til behandling af fremskreden prostatacancer for over 20 år siden. 
Vantas is a new LHRH agonist and this pharmacological class was introduced for the treatment of advanced prostate cancer more than 20 years ago.
CHMP anbefalede udstedelse af markedsføringstilladelsen, for hvilken produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III for Vantas. 
The CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III for Vantas.
Opnåelse af et kastratniveau af testosteron er et acceptabelt surrogat-endepunkt ved hormonfølsom fremskreden prostatacancer og resulterer i mindskelse af smerter fra knoglemetastaser, bedre urinflow og undertiden langsommere progression af tumor, dog uden at en fordel i form af klart bedre overlevelse er påvist. 
The achievement of castrate levels of testosterone is an acceptable surrogate endpoint in hormone sensitive advanced prostate cancer which can be translated into less pain from bone metastases, improvement in urinary flow, and in some cases slowing of tumour progression, although a clear-cut survival benefit has not been demonstrated.
Selv i den androgenuafhængige tilstand danner prostatacancer dog sandsynligvis underpopulationer af celler, der er androgenafhængige. 
However, even in the androgenindependent state, prostate cancer is likely to contain subpopulations of cells that are androgen dependent.
Det farmakologiske endepunkt, serumtestosteron < 50 ng/dl, der er dokumenteret for Vantas i undersøgelse 302 og 301 foruden i langtidsforlængelsen af undersøgelse 301, er således et acceptabelt primært endepunkt for virkning hos patienter med fremskreden prostatacancer. 
Thus, the documented pharmacological endpoint serum testosterone < 50 ng/dL, documented for Vantas in studies 302, 301 and in addition in the Long Term Extension of Study 301 is an acceptable primary efficacy endpoint in patients with advanced prostate cancer.
BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL 
ANNEX III SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET
CHMP har da også accepteret reduktion af testosteron til kastratniveau som et gyldigt surrogat for klinisk virkning ved fremskreden prostatacancer, hvilket skete i en faglig udtalelse i 2004 fra arbejdsgruppen vedrørende videnskabelig rådgivning (SAWP). 
Furthermore, reduction of testosterone to castrate levels has been accepted as a valid surrogate for clinical efficacy in advanced prostate cancer by the CHMP in 2004 as part of scientific advice from the SAWP.
I de to seneste tiår er injektion af langtidsvirkende gonadotropinfrigørende hormonanaloger (GnRH-analoger) blevet anvendt til at opnå suppression af testosteron. 
For the last two decades, injection of long-acting luteinizing hormone-releasing hormone agonists (LH-RHas) has been used to achieve androgen ablation.
Data fra langtidsforlængelsen af undersøgelse 301 vedrørende virkning og sikkerhed underbygger den langsigtede virkning og sikkerhed ved palliativ behandling af fremskreden prostatakræft med histrelin-implantat i to år eller længere. 
The data from the Long Term Extension Study 301 concerning efficacy and safety are in support for both long-term efficacy and safety for patients, receiving palliative treatment of advanced prostate cancer with histrelin implant for two or more years.
Det Forenede Kongerige (Storbritannien) 
United Kingdom
CHMP anmoder om, at de fem sikkerhedshensyn ved lægemiddelovervågningen medtages i risikostyringsplanen som ovenfor nævnt og som foreslået af ansøgeren/indehaveren af markedsføringstilladelsen. 
The CHMP requests the inclusion, as proposed by the Applicant/MAH, of the five pharmacovigilance safety concerns in the Risk Management Plan as mentioned above.
På grundlag af disse begrænsede oplysninger er vedholdende antiandrogen behandling i dag standardbehandlingen af androgen-uafhængig prostatacancer (AIPC). 
On the basis of these limited data, continued androgen suppression in men with androgenindependent prostate cancer (AIPC) is the current standard of care.
Sent i det kliniske forløb er prostatacancer uafhængig af androgen og refraktær over for hormonbehandling. 
Late in the clinical course, it is androgen independent, and is refractory to hormonal therapy.
I den tidlige del af sit spontane forløb er prostatacancer androgenafhængig. 
Early in its natural cycle, prostate cancer is androgen dependent.
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne 
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy 
AstraZeneca S.p.A. Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
1180 Ukkel Belgium 
1180 Bruxelles
Emla krém 5% lidocain prilocain 
Emla krém 5% lidocaine prilocaine
Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands creme; hydrofil 
2719 EE Zoetermeer The Netherlands cream; hydrophilic cutaneous use
NV AstraZeneca SA Rue Egide Van Ophem 110 1180 Bruxelles Belgium 
Luxembourg NV AstraZeneca SA Rue Egide Van Ophem 110
Emla 5% - Creme lidocain prilocain 
EMLA 5% w/w Cream lidocaine prilocaine
AstraZeneca B.V. 
The Netherlands AstraZeneca B.V. Louis Pasteurlaan 5
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Advate den 2. marts 2004. 
The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.
Advate er beregnet til enten kortvarig eller langvarig brug. 
Advate is intended for either short-term or long-term use.
Endvidere krævede 81 % af disse blødningsepisoder kun en enkelt behandling med Advate. 
In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Den fuldstændige EPAR for Advate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Advate 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 Advate. 
This is a summary of the European public assessment report (EPAR) for Advate.
Andre oplysninger om Advate 
Other information about Advate
Der er indberettet allergiske reaktioner, som i visse tilfælde kan være alvorlige. 
Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.
Advates virkning blev bedømt som "udmærket" eller "god" i 86 % af 510 nye blødningsepisoder. 
The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes.
Octocog alfa fremstilles ved hjælp af en metode, der kaldes "rekombinant dna-teknologi", dvs. det fremstilles af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere det. 
Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Hvorfor blev Advate godkendt? 
Why is Advate approved?
De data, der blev fremlagt om immuntoleransinduktion hos patienter med antistoffer, blev ikke betragtet som tilstrækkelige til specifikt at godkende lægemidlet til denne anvendelse. 
The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Patienten eller dennes omsorgsgiver har mulighed for selv at indgive Advate hjemme efter at have fået passende instruktion. 
Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Advate? 
What measures are being taken to ensure the safe and effective use of Advate?
Det er ikke en praktisk vejledning i, hvordan Advate bør anvendes. 
It is not intended to provide practical advice on how to use Advate.
De yderligere undersøgelser bekræftede Advates virkning, herunder hos børn under seks år. 
The additional studies confirmed Advate's effectiveness, including in children under 6 years of age.
Almindelige bivirkninger ved Advate (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine og feber. 
Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).
Advate ligner lægemidlet Recombinate, som er godkendt i EU, men det fremstilles på en anden måde, så lægemidlet ikke indeholder proteiner af human eller animalsk oprindelse. 
Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Det indeholder det aktive stof octocog alfa (human koagulationsfaktor VIII). 
It contains the active substance octocog alfa (human coagulation factor VIII).
Agenturet konkluderede, at fordelene ved Advate opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Advate. 
The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation.
I tre yderligere undersøgelser så man nærmere på anvendelsen af lægemidlet til forebyggelse af blødninger og under operation hos patienter med svær eller moderat svær hæmofili A, herunder en undersøgelse med 53 børn under seks år. 
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years.
Dosis og varighed af behandlingen afhænger af, om Advate skal anvendes til behandling eller forebyggelse af blødning eller under en operation, sygdommens sværhedsgrad, blødningens omfang og beliggenhed samt patientens tilstand og kropsvægt. 
The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Hvilke risici er der forbundet med Advate? 
What are the risks associated with Advate?
Agenturet besluttede, at det er påvist, at Advate er effektivt til at behandle og forebygge blødning hos patienter med hæmofili A og har en acceptabel sikkerhedsprofil. 
The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Hvis du ønsker yderligere oplysninger om behandling med Advate, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Advate, octocog alfa (human koagulationsfaktor VIII), er et stof, der hjælper blodet med at størkne. 
The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Hvad er Advate, og hvad anvendes det til? 
What is Advate and what is it used for?
For at vise, at de to lægemidler svarer til hinanden, er Advate derfor blevet sammenlignet med Recombinate i en hovedundersøgelse, der omfattede 111 patienter med hæmofili A. 
Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.
Advate anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødersygdommen. 
Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Advate er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter i alle aldre med hæmofili A (en arvelig blødersygdom, der skyldes mangel på faktor VIII). 
Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Advate udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hæmofili og brug af genoplivningsudstyr, hvis der opstår en alvorlig allergisk reaktion (anafylakse). 
Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).
Patienter med hæmofili A mangler faktor VIII, og det medfører problemer med blodets størkning, såsom blødning i led, muskler eller indre organer. 
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Advate bør ikke anvendes af personer, som kan være allergiske over for human koagulationsfaktor VIII, museeller hamsterproteiner eller andre af indholdsstofferne. 
Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Advate givet i høj dosis er blevet undersøgt for at se, om det nedbryder antistoffer mod faktor VIII i blodet (en proces, der kaldes immuntoleransinduktion), så behandlingen med faktor VIII forbliver effektiv. 
Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Den fuldstændige liste over indberettede bivirkninger ved Advate fremgår af indlægssedlen. 
For the full list of all side effects reported with Advate, see the package leaflet.
Advate fås som pulver og solvens, der blandes sammen til en opløsning, som gives ved injektion i en vene. 
Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Hvis du ønsker praktisk vejledning om anvendelsen af Advate, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Advate? 
How is Advate used?
Hvilke fordele viser undersøgelserne, at der er ved Advate? 
What benefits of Advate have been shown in studies?
Formålet med undersøgelsen var at se nærmere på antallet af blødningsepisoder hos 107 patienter, der alle blev behandlet med Advate, idet Advates virkning på standsningen af blødningen blev vurderet på en skala fra "ingen virkning" til "udmærket". 
The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate.
Der er den risiko ved faktor VIII-lægemidler, at visse patienter danner antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og kontrollen med blødning svigter. 
There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Advate. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate have been included in the summary of product characteristics and the package leaflet.
Hos nogle patienter kan immunsystemet danne faktor VIII-antistoffer (proteiner), som hæmmer lægemidlets virkning, så blødningen ikke længere er under kontrol. 
Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
EU/1/06/350/001 Savene mg/ml 
EU/1/06/350/001 Savene
Pulver og solvens til koncentrat til infusionsvæske, opløsning 
Powder and solvent for concentrate for solution for infusion
25 ml (20 mg/ml) Solvens: 500 ml hætteglas 3 flasker 
concentrate: 25 ml (20 mg/ml); diluent: 500 ml
Solvens: flaske (glas) 
Intravenous use powder: vial (glass); bottle (glass)
Koncentrat: 
Content (concentration)
7 (7x1) hætteglas + 7 (7x1) fyldte injektionssprøjter med solvens + 7 (7x1) hætteglasadaptere + 7 (7x1) kanyler + 14 (7x2) servietter (flerstyks pakning) 
7 (7 x 1) vials + 7 (7 x 1) pre-filled solvent syringes + 7 (7 x 1) vial adapters + 7 (7 x 1) needles + 14 (7 x 2) swabs (multipack)