FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex related to the Art. 127a Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Danish: Annex relateret til artikel 127a Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som skal implementeres af medlemslandet
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States 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: The Member State shall agree the details of the Prescriber kit and a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally prior to launch to ensure that:
Danish: Medlemslandet skal aftale detaljerne i ordinationssættet og et kontrolleret distributionssystem med indehaveren af markedsføringstilladelsen og implementere det inden lancering nationalt for at sikre at:
English: If you have severe kidney problems, you should not take Urorec.
Danish: Hvis De har alvorlige nyreproblemer, bør De ikke tage Urorec.
English: If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
Danish: Hvis de har moderate nyreproblemer, vil Deres læge begynde behandlingen med Urorec med forsigtighed og muligvis med en lavere dosis (se punkt 3 “Dosis”).
English: Urorec has minor or moderate influence on the ability to drive and use machines.
Danish: Urorec påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: This effect disappears after discontinuation of Urorec.
Danish: Denne virkning forsvinder, når behandlingen med Urorec ophører.
English: There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Danish: Der er utilstrækkelig information om sikker anvendelse af silodosin i forbindelse med andre α-adrenoreceptorantagonister.
English: Difference (95 % CI) vs placebo
Danish: Forskel (95 % KI) versus placebo
English: Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Danish: Urorec tilhører en gruppe af lægemidler, der kaldes alfa1A-adrenoreceptorblokkere.
English: Dizziness when standing up and occasionally fainting may occur when taking Urorec, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Danish: Hvis De oplever svimmelhed, når De rejser Dem op, og hvis De besvimer ind imellem, når De tager Urorec, specielt når De begynder med behandlingen, eller hvis De tager andre lægemidler, der sænker blodtrykket.
English: It is important that you immediately inform your eye specialist if you are using or have previously used Urorec.
Danish: Det er vigtigt, at De straks informerer Deres øjenspecialist, hvis De tager eller tidligere har taget Urorec.
English: What you need to know before you take Urorec Do not take Urorec if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Urorec Tag ikke Urorec hvis De er allergisk over for silodosin eller et af de øvrige indholdsstoffer i Urorec (angivet i punkt 6).
English: Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.
Danish: Spørg Deres læge om De bør udskyde eller midlertidigt stoppe med at tage Urorec, hvis De skal gennemgå en operation for grå stær.
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec.
Danish: • Da en godartet forstørrelse af blærehalskirtlen og prostatakræft kan have de samme symptomer, vil Deres læge undersøge Dem for prostatakræft, før De begynder behandlingen med Urorec.
English: Yellow iron oxide (E172) (4 mg capsules only)
Danish: Gul jernoxid (E172) (kun 4 mg kapsel)
English: For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below).
Danish: Til specielle patientpopulationer anbefales en kapsel Urorec 4 mg dagligt (se nedenfor).
English: • If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
Danish: • Hvis De har alvorlige leverproblemer, bør De ikke tage Urorec, da det ikke er undersøgt i forbindelse med alvorlig leversygdom.
English: Date of latest renewal: 18/09/2014
Danish: Dato for første markedsføringstilladelse: 29/01/2010 Dato for seneste fornyelse: 18/09/2014
English: Talk to your doctor or pharmacist before taking Urorec
Danish: Kontakt lægen eller apotekspersonalet, før De tager Urorec.
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Urorec.
Danish: • Hvis De skal gennemgå en øjenoperation på grund af uklarhed af linsen (operation for grå stær), er det vigtigt, at De straks informerer Deres øjenspecialist om, at De tager eller tidligere har taget Urorec.
English: Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Danish: Urorec kan forårsage komplikationer under en operation for grå stær (øjenoperation på grund af en uklar linse, se punktet “Advarsler og forsigtighedsregler”).
English: Urorec is not intended for use by women.
Danish: Urorec er kun beregnet til brug hos mænd.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.
Danish: • medicin mod epilepsi eller rifampicin (medicin til behandling af tuberkulose), da virkningen af Urorec kan være nedsat.
English: Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Danish: Urorec findes i pakningsstørrelser med 5, 10, 20, 30, 50, 90 og 100 kapsler.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
Danish: • medicin, der sænker blodtrykket (især medicin kaldet alfa1-blokkere, såsom prazosin eller doxazosin), da der kan være en risiko for at virkningen af sådanne former for medicin forstærkes, mens De tager Urorec.
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec.
Danish: • Hvis De på noget tidspunkt er besvimet eller har følt Dem svimmel, når De pludseligt rejser Dem op, skal De informere lægen før De tager Urorec.
English: If you stop taking Urorec
Danish: Hvis De holder op med at tage Urorec
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Danish: I et klinisk fase IV-studie, der blev udført i Europa, med en gennemsnitlig IPSS total-score ved baseline på 18,9 points, havde 77,1 % respons på silodosin (vurderet ved en ændring i IPSS total-score fra baseline på mindst 25 %).
English: Elimination Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Danish: Efter oral administration af 14C-mærket silodosin blev ca. 33,5 % og 54,9 % af radioaktiviteten genfundet i henholdsvis urin og afføring efter 7 dage.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Urorec in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med med referencelægemidlet, som indeholder Urorec i alle undergrupper af den pædiatriske population med BPH (se pkt.
English: Urorec does not treat prostate cancer.
Danish: Urorec kan ikke anvendes til at behandle prostatakræft.
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Danish: Over 800 patienter med moderate til svære symptomer på BPH (International Prostate Symptom Score, IPSS, baseline-værdi ≥ 13) fik silodosin 8 mg én gang dagligt i to placebo-kontrollerede kliniske fase III-studier udført i USA, og i et placebo-kontrolleret og aktivt kontrolleret klinisk studie udført i Europa.
English: If you forget to take Urorec
Danish: Hvis De har glemt at tage Urorec
English: Urorec is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Danish: Urorec anvendes hos voksne mænd for at behandle urinsvejssymptomer forbundet med en godartet forstørrelse af blærehalskirtlen (prostatahyperplasi), såsom:
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Urorec might lead to a slight decrease in blood pressure.
Danish: • medicin til behandling af problemer med at få og opretholde en erektion (såsom sildenafil eller tadalafil), da samtidig anvendelse med Urorec kan føre til et let blodtryksfald.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Urorec.
Danish: • medicin mod svampeinfektion (såsom ketoconazol eller itraconazol), medicin der anvendes mod HIV-infektion/AIDS (såsom ritonavir) eller medicin der anvendes efter transplantationer for at forhindre organafstødning (såsom ciclosporin), da disse former for medicin kan forhøje koncentrationen af Urorec i blodet.
English: There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Danish: Det er ikke relevant at anvende Urorec hos den pædiatriske population til indikationen godartet prostatahyperplasi (BPH).
English: • The treatment with Urorec may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Danish: • Behandling med Urorec kan føre til unormal ejakulation (reduktion i mængden af sæd, der frigives under samleje), hvilket midlertidigt kan påvirke den mandlige frugtbarhed.
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Danish: I et dobbelt-blindet, placebo-kontrolleret klinisk dose-finding, fase II-studie med silodosin 4 eller 8 mg én gang dagligt, blev der observeret en større forbedring i index score af symptomer i henhold til American Urologic Association (AUA) med silodosin 8 mg (-6,8 ± 5,8; n = 90; p = 0,0018) og silodosin 4 mg (-5,7 ± 5,5; n= 88; p = 0,0355) sammenlignet med placebo (-4,0 ± 5,5; n = 83).
English: Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Danish: Potente CYP3A4-hæmmere (såsom ketoconazol, itraconazol, ritonavir eller ciclosporin) bør ikke anvendes samtidig med Urorec.
English: Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Danish: Urorec kan nedsætte mængden af sædceller og dermed midlertidigt påvirke Deres evne til at gøre en kvinde gravid.
English: The recommended dose is one capsule of Urorec 8 mg daily.
Danish: Den anbefalede dosis er én kapsel Urorec 8 mg dagligt.
English: Česká republika Herbacos Recordati s.r.o.
Danish: Herbacos Recordati s.r.o.
English: Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Danish: Da der kun er begrænset erfaring med patienter med moderat nedsat nyrefunktion (n = 35), anbefales en lavere startdosis på 4 mg. Urorec bør ikke anvendes til patienter med svært nedsat nyrefunktion.
English: Österreich Haemo Pharma GmbH Tel: + 43 2689 31160
Danish: Haemo Pharma GmbH Tel: + 43 2689 31160
English: Other medicines and Urorec
Danish: Brug af anden medicin sammen med Urorec
English: For this purpose Urorec 4 mg hard capsules are available.
Danish: Til dette formål findes Urorec 4 mg hårde kapsler.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Urorec is selective for the receptors located in the prostate, bladder and urethra.
Danish: Urorec påvirker nogle receptorer, som findes i blærehalskirtlen, blæren og urinrøret.
English: The recommended dose is one capsule of Urorec 8 mg per day by oral administration.
Danish: Den anbefalede dosis er en kapsel Urorec 8 mg pr. dag givet oralt (gennem munden).
English: Urorec 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Danish: Urorec 4 mg er gule, uigennemsigtige, hårde gelatinekapsler, størrelse 3 (cirka 15,9 x 5,8 mm).
English: Deutschland Recordati Pharma GmbH Tel: + 49 731 70470
Danish: Recordati Pharma GmbH Tel: + 49 731 70470
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: United Kingdom Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
Danish: Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576336
English: Recordati Hellas Pharmaceuticals A.E. Τηλ: + 30 210-6773822
Danish: Τηλ: + 30 210-6773822
English: Urorec 4 mg and 8 mg hard capsules
Danish: Urorec 4 mg og 8 mg hårde kapsler
English: Urorec 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Danish: Urorec 4 mg hårde kapsler Hver hård kapsel indeholder 4 mg silodosin.
English: Urorec 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Danish: Urorec 8 mg hårde kapsler Hver hård kapsel indeholder 8 mg silodosin.
English: What Urorec looks like and contents of the pack Urorec 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Danish: Urorec 8 mg er hvide, uigennemsigtige, hårde gelatinekapsler, størrelse 0 (cirka 21,7 x 7,6 mm).
English: How to take Urorec
Danish: Sådan skal De tage Urorec
English: Papaloisou Ltd. Τηλ: + 357 22 49 03 05
Danish: Τηλ: + 357 22 49 03 05
English: EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010 EU/1/09/608/011 EU/1/09/608/012 EU/1/09/608/013 EU/1/09/608/014
Danish: EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010
English: Laboratoires Bouchara-Recordati Tél: + 33 1 45 19 10 00
Danish: Tél: + 33 1 45 19 10 00
English: België/Belgique/Belgien Recordati Ireland Ltd.
Danish: België/Belgique/Belgien
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Urorec 4 mg hard capsules
Danish: Urorec 4 mg hårde kapsler
English: Urorec 8 mg hard capsules Urorec 4 mg hard capsules
Danish: Urorec 4 mg hårde kapsler Urorec 8 mg hårde kapsler
English: Urorec 8 mg hard capsules
Danish: Urorec 8 mg hårde kapsler
English: What Urorec is and what it is used for What you need to know before you take Urorec How to take Urorec
Danish: Det skal De vide, før De begynder at tage Urorec Sådan skal De tage Urorec Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules silodosin
Danish: Urorec 4 mg hårde kapsler silodosin
English: NAME OF THE MEDICINAL PRODUCT Urorec 8 mg hard capsules silodosin
Danish: Urorec 8 mg hårde kapsler silodosin
English: What Urorec is
Danish: Urorecs anvendelse
English: INFORMATION IN BRAILLE Urorec 4 mg
Danish: INFORMATION I BRAILLESKRIFT
English: If you take more Urorec than you should
Danish: Hvis De har taget for meget Urorec
English: The active substance is silodosin.
Danish: Urorec 4 mg Aktivt stof: silodosin.
English: NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules
Danish: Indlægsseddel: Information til patienten Urorec 8 mg hårde kapsler
English: These issues were considered to be of serious public health concern.
Danish: Disse spørgsmål blev anset for at udgøre et alvorligt problem for folkesundheden.
English: The Applicant provided written explanations on 30 November 2007 and on 3 March 2008.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 30. november 2007 og den 3. marts 2008.
English: The final opinion was converted into a Decision by the European Commission on 22 July 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 22. juli 2008.
English: The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.
Danish: Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Østrig, Tyskland, Finland, Irland, Italien, Luxembourg, Nederlandene og Sverige.
English: The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions.
Danish: Voldgiftsproceduren indledtes den 20. september 2007 med vedtagelsen af en liste med spørgsmål.
English: The Decentralised Procedure UK/H/0892/01/DC started on 12 April 2006.
Danish: Den decentraliserede procedure UK/H/0892/01/DC indledtes den 12. april 2006.
English: The conditions of the Marketing Authorisation are provided in Annex IV.
Danish: Betingelserne for markedsføringstilladelsen fremgår af bilag IV.
English: These Member States were not able to reach an agreement and therefore the United Kingdom referred the reasons for disagreement to the CHMP on 27 July 2007.
Danish: Disse medlemsstater kunne ikke nå til enighed, og Det Forenede Kongerige fremsendte derfor begrundelserne for uenigheden til CHMP den 27. juli 2007.
English: The Rapporteur was Dr Tomas Salmonson (SE) and Co-Rapporteur was Dr Ian Hudson (UK).
Danish: Dr. Tomas Salmonson (SE) var rapportør, og dr. Ian Hudson (UK) var medrapportør.
English: London, 23 July 2008 EMEA/CHMP/428671/2008
Danish: London, den 23. juli 2008 EMEA/CHMP/222164/2008
English: Significant difference had been identified with regard to the lack of sufficient safety and efficacy evidence, the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio.
Danish: Der var blevet påvist signifikant forskel med hensyn til manglen på tilstrækkelig dokumentation for sikkerhed og effekt, forekomst af bakteriel resistens forårsaget af brugen af Oracea og utilstrækkelig påvisning af et positivt benefit/risk-forhold.
English: Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.
Danish: Oracea, 40 mg, kapsler med modificeret udløsning er et antibiotikum (doxycyclin), indiceret til reduktion af papulopustuløse læsioner hos voksne patienter med facial rosacea.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea International Non-Proprietary Name (INN): doxycycline monohydrate
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Oracea Internationalt fællesnavn (INN): doxycyclinmonohydrat
English: The list of the medicinal 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.
Danish: Listen over lægemidlernes produktnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
English: The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006.
Danish: Ansøgeren, FGK Representative Service GmbH, indgav en ansøgning om markedsføringstilladelse for Oracea, 40 mg, kapsler med modificeret udløsning på grundlag af ansøgningen om markedsføringstilladelse i Det Forenede Kongerige den 28. februar 2006.
English: A positive opinion was therefore adopted by consensus on 24 April 2008 and the grounds for opinion, the conditions of the Marketing Authorisation and the amended SPC, labelling and package leaflet of the relevant Member State were annexed.
Danish: Der blev derfor vedtaget en positiv udtalelse ved konsensus den 24. april 2008, og begrundelsen for udtalelsen, betingelserne for markedsføringstilladelsen og det ændrede produktresumé, etikettering og indlægsseddel for den relevante medlemsstat blev vedlagt.
English: During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget var CHMP på mødet i april 2008 af den opfattelse, at de indvendinger, der udløste indbringelsen i henhold til artikel 29, ikke burde forhindre udstedelse af markedsføringstilladelse for Oracea, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: Perjeta is used in the following situations:
Danish: Perjeta anvendes i følgende situationer:
English: Perjeta received a marketing authorisation valid throughout the European Union on 4 March 2013.
Danish: Perjeta fik en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 4. marts 2013.
English: The full EPAR for Perjeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Perjeta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Perjeta
Danish: Andre oplysninger om Perjeta
English: Treatment with Perjeta should be interrupted or stopped permanently if the patient gets certain side effects.
Danish: Behandling med Perjeta bør afbrydes eller stoppes permanent, hvis patienten får visse bivirkninger.
English: As for all medicines, data on the use of Perjeta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Perjeta løbende overvåget.
English: The recommended first dose is 840 mg given over one hour.
Danish: Den anbefalede indledende dosis er 840 mg, der gives over en time.
English: What measures are being taken to ensure the safe and effective use of Perjeta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Perjeta?
English: An overview of Perjeta and why it is authorised in the EU
Danish: En oversigt over Perjeta, og hvorfor det er godkendt i EU
English: It also activates cells of the immune system (the body's natural defences), which then kill the cancer cells.
Danish: Desuden aktiverer det cellerne i immunsystemet (kroppens naturlige forsvar), så de dræber kræftcellerne.