FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinplava 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 Zinplava.
English: Zinplava given during antibiotic treatment was shown to be more effective than placebo (a dummy treatment) at preventing a new episode of diarrhoea caused by C. difficile infection in 2 main studies involving a total of 2,655 patients.
Danish: Det er i to hovedundersøgelser med i alt 2 655 patienter påvist, at Zinplava, når det gives under antibiotisk behandling, er mere effektivt end placebo (en virkningsløs behandling) til at forebygge nye tilfælde af diarré forårsaget af C. difficile-infektion.
English: What benefits of Zinplava have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zinplava?
English: How is Zinplava used?
Danish: Hvordan anvendes Zinplava?
English: How does Zinplava work?
Danish: Hvordan virker Zinplava?
English: 21 October 2010
Danish: 21. oktober 2010
English: Intrinsa has been authorised since July 2006.
Danish: Intrinsa har været godkendt siden juli 2006.
English: The main measure of effectiveness was based on how frequently the women had ‘satisfying sexual episodes'.
Danish: Det primære effektmål var baseret på, hvor tit kvinderne havde "tilfredsstillende seksuelle episoder".
English: The company presented results of four studies in a total of 2,245 women with HSDD.
Danish: Virksomheden fremlagde resultaterne af fire undersøgelser, der omfattede i alt 2 245 kvinder med HSDD.
English: The full European Public Assessment Report for Intrinsa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Intrinsa findes på EMA's websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Intrinsa?
Danish: Hvad er Intrinsa?
English: What is happening with Intrinsa for its existing indication?
Danish: Hvad sker der med Intrinsa i den eksisterende indikation?
English: These women will also be receiving treatment with an oestrogen (a female sex hormone).
Danish: Disse kvinder vil også modtage behandling med et østrogen (et kvindeligt kønshormon).
English: The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Danish: Plasteret afgiver 300 mikrogram af det aktive stof testosteron i løbet af 24 timer.
English: They were given either Intrinsa or placebo (a dummy treatment).
Danish: De fik enten Intrinsa eller placebo (en virkningsløs behandling).
English: Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Danish: Intrinsa er et depotplaster (et plaster, der afgiver et lægemiddel gennem huden).
English: This means that the CHMP had evaluated the documentation provided by the company and formulated two lists of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet to lister med spørgsmål.
English: The CHMP noted that there was insufficient long-term data on the safety of the medicine in this larger group of patients and was therefore of the opinion that the medicine's benefits in these women did not outweigh its risks.
Danish: CHMP bemærkede, at der var utilstrækkelige langtidsdata om lægemidlets sikkerhed hos denne udvidede patientgruppe, og CHMP var derfor af den opfattelse, at lægemidlets fordele for disse kvinder ikke opvejer risiciene.
English: The amount of testosterone in the blood is reduced after the menopause.
Danish: Mængden af testosteron i blodet falder efter menopausen.
English: What was Intrinsa expected to be used for?
Danish: Hvad forventedes Intrinsa anvendt til?
English: On 22 September 2010, Warner Chilcott Pharmaceuticals UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Intrinsa, to extend treatment to all postmenopausal women with hypoactive sexual desire disorder.
Danish: Den 22. september 2010 meddelte Warner Chilcott Pharmaceuticals UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om ændring af markedsføringstilladelsen for Intrinsa til også at omfatte behandling af alle postmenopausale kvinder med hypoaktiv seksuel lyst (HSDD).
English: The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Danish: Det aktive stof i Intrinsa, testosteron, er et naturligt kønshormon, der dannes hos mænd og i mindre omfang hos kvinder.
English: Intrinsa was expected to be used to treat HSDD in postmenopausal women with or without hormone treatment.
Danish: Intrinsa forventedes anvendt til behandling af HSDD hos postmenopausale kvinder med eller uden hormonbehandling.
English: Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Intrinsa could not have been approved for use in all postmenopausal women who have HSDD.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Intrinsa ikke kunne have været godkendt til behandling af alle postmenopausale kvinder, som har HSDD.
English: How is Intrinsa expected to work?
Danish: Hvordan forventes Intrinsa at virke?
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Danish: Lave testosteronniveauer er blevet forbundet med nedsat seksuel lyst, reducerede seksuelle tanker og nedsat seksuel ophidselse.
English: Some of the women had their womb and both ovaries surgically removed while others were postmenopausal women who had not had their womb or ovaries removed.
Danish: Nogle af kvinderne havde fået deres livmoder og begge æggestokke fjernet kirurgisk, mens andre var postmenopausale kvinder, som ikke havde fået deres livmoder eller æggestokke fjernet.
English: It is already used to treat women with hypoactive sexual desire disorder (HSDD, a lack of sexual thoughts and sexual desire) who have had their womb and both ovaries surgically removed.
Danish: Det anvendes allerede til behandling af kvinder med hypoaktiv seksuel lyst (HSDD, som er en mangel på seksuelle tanker og seksuel lyst), der har fået fjernet livmoderen og begge æggestokke kirurgisk.
English: The company informed the CHMP that there are no consequences for patients currently in clinical trials or compassionate use programmes with Intrinsa.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Intrinsa eller i programmer for anvendelse af Intrinsa med særlig udleveringstilladelse.
English: This was to incude all women who have been through the menopause and not only those who are ‘surgically postmenopausal' as result of having had their womb or ovaries removed.
Danish: Ændringen skulle foretages for at medtage alle kvinder, der har været igennem menopausen, og ikke kun de kvinder, der befinder sig i en "kirurgisk induceret menopause", fordi de har fået fjernet livmoderen eller æggestokkene.
English: In postmenopausal women, Intrinsa was expected to release testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before the menopause.
Danish: Det forventedes, at Intrinsa skulle afgive testosteron til blodet gennem huden hos postmenopausale kvinder for at skabe de samme testosteronniveauer som før menopausen.
English: There are no consequences on the use of Intrinsa in the treatment of HSDD in women who have had their womb and both ovaries removed.
Danish: Der er ingen konsekvenser for brugen af Intrinsa til behandling af HSDD hos kvinder, som har fået livmoderen og begge æggestokke fjernet.
English: The application was withdrawn after ‘day 90'.
Danish: Ansøgningsproceduren var ved dag 90, da virksomheden trak sin ansøgning tilbage.
English: Intrinsa is expected to work in the same way as it does in women who have had their womb and both ovaries surgically removed.
Danish: Intrinsa forventes at virke på samme måde, som det virker hos kvinder, der har fået fjernet livmoderen og begge æggestokke kirurgisk.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Intrinsa eller i programmer for anvendelse af Intrinsa med særlig udleveringstilladelse?
English: Because consensus could not be reached, the procedure was
Danish: Da der ikke kunne opnås enighed, blev
English: London, 17 March 2009 Doc.
Danish: London, den 17. marts 2009 Dok.
English: The company wanted the authorisation to be granted in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia and Spain (the concerned Member States).
Danish: Virksomheden ansøgte om markedsføringstilladelse i Østrig, Belgien, Bulgarien, Den Tjekkiske Republik, Danmark, Estland, Frankrig, Tyskland, Italien, Letland, Litauen, Luxembourg, Norge, Polen, Portugal, Slovakiet, Slovenien og Spanien (de berørte medlemsstater).
English: The review was carried out under an ‘Article 29' referral1 procedure.
Danish: Undersøgelsen blev gennemført i henhold til en ”artikel 29-indbringelse”1.
English: Ref. EMEA/CHMP/191900/2009 EMEA/H/A-29/1096
Danish: ref. EMEA/189562/2009 EMEA/H/A-29/1096
English: As a result the cells cannot multiply.
Danish: Cellerne kan således ikke formere sig.
English: What is Bleomycin?
Danish: Hvad er Bleomycin?
English: Referral start date:
Danish: Startdato for henvisning:
English: Why was Bleomycin reviewed?
Danish: Hvorfor blev Bleomycin vurderet igen?
English: Germany considered that the submitted data was insufficient for granting a marketing authorisation for the proposed indications.
Danish: Tyskland fandt ikke, at de indsendte data var tilstrækkelige til at kunne udstede markedsføringstilladelse til de foreslåede indikationer.
English: referred to the CHMP.
Danish: sagen henvist til CHMP.
English: Bleomycin is a cytostatic substance; this means that it stops the growth of cells.
Danish: Bleomycin er et cytostatikum, hvilket betyder, at det standser cellernes vækst.
English: Bleomycin is almost always used in combination with anti-cancer drugs or in combination with radiation.
Danish: Bleomycin anvendes næsten altid i kombination med lægemidler mod cancer eller i kombination med strålebehandling.
English: The grounds for the referral were that Germany was not in a position to accept some of the anti-cancer indications because they were not recognised as acceptable for bleomycin in the country.
Danish: Årsagerne til henvisningen var, at Tyskland ikke kunne godkende visse af indikationerne for behandling af cancer, da disse ikke var godkendt for bleomycin i Tyskland.
English: The RMS and the other positive CMSs were in favour of retaining these indications.
Danish: Referencemedlemsstaten og de andre positive berørte medlemsstater ønskede at bevare disse indikationer.
English: On 3 November 2008, the Netherlands medicines regulatory agency, the Medicines Evaluation Board, referred the matter to the CHMP.
Danish: Disse medlemsstater kunne ikke nå til enighed, og den 3. november 2008 henviste den nederlandske lægemiddelstyrelse spørgsmålet til CHMP.
English: Bleomycin is an anti-cancer medicine used to treat certain forms of cancer of the head or the neck, cervix (the neck of the womb) and external sexual organs; certain forms of lymphoma (cancer of the lymphatic system) such as Hodgkin's disease; and to treat cancer of the testicles.
Danish: Bleomycin er et lægemiddel mod cancer, der anvendes til behandling af visse former for hoved- og halscancer, cancer i livmoderhals og ydre kønsdele, visse former for lymfomer (cancer i det lymfatiske system), såsom Hodgkins syge, samt til behandling af testikelcancer.
English: Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/Vial, from Pharmachemie BV
Danish: Spørgsmål og svar om indbringelsen af sagen vedrørende Bleomycin pulver til injektionsvæske, opløsning, 15 E pr. hætteglas, fra Pharmachemie BV
English: The indications ‘head and neck carcinoma' and ‘epidermoid carcinoma of external genitalia such as penile carcinoma, or cervix' had been deleted from the authorised indications for all bleomycin-containing products in Germany because the balance of benefit/risk for bleomycin in these indications was considered negative.
Danish: Indikationerne "hoved- og halscarcinoma" og "epidermoide carcinomer i de ydre kønsdele, såsom peniscancer eller cancer i livmoderhalsen," var blevet fjernet fra listen over godkendte indikationer for alle bleomycinprodukter i Tyskland, da benefit/risk-forholdet for bleomycin ved disse indikationer blev betragtet som negativt.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Bleomycin injection, from Pharmachemie BV.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en procedure for indbragte sager efter en uoverensstemmelse mellem visse medlemsstater i Den Europæiske Union angående udstedelse af markedsføringstilladelse for lægemidlet Bleomycin injektionsvæske fra Pharmachemie BV.
English: Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
Danish: Pharmachemie BV indsendte en ansøgning om markedsføringstilladelse for Bleomycin pulver til injektionsvæske, opløsning, 15 E pr. hætteglas, via den decentraliserede procedure den 10. juli 2007 med Nederlandene som referencemedlemsstat.
English: Based on evaluation of the currently available data, including published literature and current treatment guidelines, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and therefore the marketing authorisation for Bleomycin should be granted in all concerned member states.
Danish: På grundlag af en vurdering af de tilgængelige data, herunder den offentliggjorte faglitteratur og de gældende behandlingsretningslinjer, og den faglige drøftelse i udvalget konkluderede CHMP, at den gavnlige virkning af Bleomycin injektionsvæske, opløsning, fra Pharmachemie BV er større end risiciene, og at der derfor kan udstedes markedsføringstilladelse for Bleomycin i alle de berørte medlemsstater.
English: Bleomycin can also be used by injection directly inside the chest cavity to treat fluid accumulation in the lungs as a result of cancer.
Danish: Bleomycin kan endvidere indgives ved injektion direkte i brysthulen (cavitas thoracis) til behandling af væskeophobning i lungerne som følge af cancer.
English: Opinion date:
Danish: Udtalelsesdato:
English: Bleomycin inserts itself within the strands of DNA, the genetic material of cells, making the strands break.
Danish: Bleomycin indsætter sig i dna-strengene, cellernes arvemateriale, og får dem til at briste.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and the marketing authorisation can be granted in the Member States of the European Union and the European Economic Area.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at den gavnlige virkning af Bleomycin injektionsvæske, opløsning, fra Pharmachemie BV er større end risiciene, og at der kan udstedes markedsføringstilladelse for lægemidlet i EU-medlemsstaterne og landene i Det Europæiske Økonomiske Samarbejdsområde.
English: EU/1/06/368/057 Insulin Human Winthrop Infusat
Danish: Insulin Human Winthrop Infusat
English: 40 IU/ml Solution for injection
Danish: Injektionsvæske, opløsning
English: EMEA/436209/2008
Danish: EMEA/436209/2008-DA
English: London, September 2008 EMEA/436209/2008
Danish: London, 26.09.2008 EMEA/436209/2008
English: • The benefit/risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age.
Danish: • Det blev påvist, at produktets benefit/risk-forhold var positivt, men det skal fremgå af produktresuméet, at lægemidlet ikke bør anvendes til nyfødte eller meget unge kalve, der er mindre end 2 uger gamle og smågrise, der er mindre end 4 uger gamle.
English: The CVMP Opinion was adopted on 16 July 2008 and the subsequent Commission Decision adopted on 26 September 2008.
Danish: CVMP vedtog sin udtalelse den 16.07.2008, og Kommissionen vedtog den efterfølgende beslutning den 26.09.2008.
English: OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR SODIUM SALICYLATE
Danish: UDVALGET FOR VETERINÆRLÆGEMIDLER (CVMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 35 VEDRØRENDE NATRIUMSALICYLAT
English: --1Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Danish: --1 Levende svækket bovint, respiratorisk syncytialvirus (BRSV), stamme Lym-56 104,7 - 6,5 CCID50* *Infektionsdosis i cellekultur 50 %
English: Content
Danish: Tilbageholdelsestid
English: Package size Withdraw al period
Danish: Indhold Pakningss -tørrelse
English: Intravenous use vial (glass)
Danish: Til intravenøs anvendelse hætteglas (glas)
English: 20 mg
Danish: 20 mg hætteglas
English: Pack size
Danish: Paknings størrelse
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold (koncentration)
English: 1 vial
Danish: (Sær)navn
English: Date of first authorisation: 16 September 1998 Date of latest renewal: 3 September 2008
Danish: Dato for første markedsføringstilladelse: 16 september 1998 Dato for seneste fornyelse: 3 september 2008
English: When Comtess is given at higher doses:
Danish: Hvis Comtess gives i større doser:
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger
English: • altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive;
Danish: • Ændret eller øget seksuel interesse og opførsel, der skaber bekymring for dig eller andre, for eksempel øget sexlyst
English: • Inability to resist the impulse to perform an action that could be harmful, which may include:
Danish: • Manglende evne til at modstå trangen til at gøre noget, som kan være skadeliget, hvilket kan være:
English: General characteristics of the active substance Absorption
Danish: Generelle karakteristika af det aktive indholdsstof Absorption
English: There are large intra- and interindividual variations in the absorption of entacapone.
Danish: Der er store intra- og internindividuelle variationer i absorptionen af entacapon.
English: • binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Danish: • Spiseorgie (spiser store mængder mad på meget kort tid) eller tvangsspisning (spiser mere mad end normalt eller mere end der skal til for at gøre dig mæt).
English: EU/1/98/082/001 30 film-coated tablets EU/1/98/082/002 60 film-coated tablets EU/1/98/082/003 100 film-coated tablets EU/1/98/082/005 175 film-coated tablets
Danish: EU/1/98/082/001 30 filmovertrukne tabletter EU/1/98/082/002 60 filmovertrukne tabletter EU/1/98/082/003 100 filmovertrukne tabletter EU/1/98/082/005 175 filmovertrukne tabletter
English: Comtess may make it harder for you to digest iron.
Danish: Comtess kan gøre det sværere at optage jern.
English: If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa.
Danish: Hvis du oplever sådanne bivirkninger i begyndelsen af behandlingen med Comtess, skal du kontakte din læge, som kan vælge at justere din levodopadosis.
English: If you stop taking Comtess Do not stop taking Comtess unless your doctor tells you to.
Danish: Hvis du holder op med at tage Comtess Du må kun ophøre med at tage Comtess, hvis din læge har sagt det.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Danish: I et interaktionsstudie med raske forsøgspersoner sås ingen ændringer af S-warfarin på plasmaniveau, mens AUC for R-warfarin i gennemsnit øgedes med 18% [CI90 11-26%].
English: Comtess and iron supplements at the same time.
Danish: Du må derfor ikke tage Comtess og jerntilskud på samme tid.
English: Do not take Comtess
Danish: Tag ikke Comtess
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Danish: Dyskinesier (27%), kvalme (11%), diarré (8%), abdominale smerter (7%) og mundtørhed (4,2%) blev rapporteret signifikant hyppigere med entacapon end placebo i poolede data fra kliniske studier, hvor 406 patienter har fået den aktive medicin, og 296 patienter har fået placebo.
English: Do not use Comtess during pregnancy or if you are breast-feeding.
Danish: Du må ikke tage Comtess under graviditet, eller hvis du ammer.
English: If you forget to take Comtess
Danish: Hvis du har glemt at tage Comtess
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtess and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Danish: Malignt neuroleptika syndrom (MNS) er en alvorlig, men sjælden reaktion på visse lægemidler, som især kan forekomme, hvis behandling med Comtess og andre lægemidler til behandling af Parkinsons sygdom pludseligt stoppes, eller hvis dosis pludseligt nedsættes.
English: Suddenly stopping Comtess and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Danish: Pludseligt stop med brug af Comtess og anden medicin til behandling af Parkinsons sygdom kan give uønskede bivirkninger.
English: As Comtess tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Danish: Da Comtess-tabletter skal tages sammen med andre levodopa-lægemidler, skal du også læse indlægssedlen for disse lægemidler omhyggeligt.
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60, 100 or 175 tablets.
Danish: Hvid high-density polyethylen (HDPE) beholder med hvidt forseglet polypropylen (PP) låg indeholdende 30, 60, 100 eller 175 tabletter.
English: Experience with Comtess in patients under 18 years is limited.
Danish: Der er begrænset erfaring med brug af Comtess til patienter under 18 år.
English: • if you are allergic to entacapone or to peanut or soya or any of the other ingredients of this medicine (listed in section 6);
Danish: • hvis du er allergisk over for entacapon eller over for jordnødder eller soja eller et af de øvrige indholdsstoffer i Comtess (angivet i punkt 6);