FrancophonIA/ELRC3.0 huggingface dataset:
English: Remove the volume of Zoledronic acid medac solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% w/v glucose solution for injection.
Danish: Udtag den angivne mængde af Zoledronsyre medac-opløsning fra flasken og erstat med en tilsvarende mængde steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller 5 % glucose, injektionsvæske, opløsning.
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Danish: Akut nyresvigt, hæmaturi, proteinuri Erhvervet Fanconis syndrom Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Multiple event analysis showed a 36 % risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste en risikoreduktion på 36 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
English: LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Danish: ETIKET PÅ MULTIPAKNINGER MED 4 FLASKER PAKKET I TRANSPARENT FOLIE (INKLUSIVE ”BLÅ BOKS”)
English: • History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures.
Danish: • Tandsygdom i anamnesen, dårlig mundhygiejne, parodontal sygdom, invasiv tandbehandling
English: • Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Danish: • Samtidige behandlinger, kemoterapi, angiogenesehæmmere (se pkt.
English: Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml
Danish: Multipakning 10 x 1 hætteglas med 5 ml.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion anbefales nedsatte doser af zoledronsyre (se pkt.
English: LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Danish: ETIKET PÅ MULTIPAKNINGER MED 10 FLASKER PAKKET I TRANSPARENT FOLIE (INKLUSIVE ”BLÅ BOKS”)
English: Efficacy results are provided in Table 3.
Danish: Resultaterne for virkning kan ses i Tabel 3.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 4 BOTTLES CARTON FOR 1 BOTTLE AS PART OF A MULTIPACK COMPRISING 10 BOTTLES
Danish: KARTON TIL 1 FLASKE SOM DEL AF EN MULTIPAKNING, DER INDEHOLDER 4 FLASKER
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: For at undgå eventuelle uforligeligheder skal der enten bruges natriumchlorid- 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller 5 % w/v glucoseopløsning som infusionsvæske til fortynding.
English: What Zoledronic acid medac is and what it is used for What you need to know before you are given Zoledronic acid medac How Zoledronic acid medac is used Possible side effects
Danish: Det skal du vide, før du får Zoledronsyre medac Sådan skal du bruge Zoledronsyre medac Bivirkninger
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Danish: Forebyggelse af skeletrelaterede hændelser hos patienter med fremskredne maligniteter, som omfatter knoglerne.
English: Episcleritis
Danish: Hypokalcæmi
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 4 mg of zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En flaske indeholder 4 mg zoledronsyre (som monohydrat).
English: Manufacturer Sanochemia Pharmazeutika AG
Danish: Sanochemia Pharmazeutika AG Landegger Straße 7
English: Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 cartons each containing 1 bottle.
Danish: Zoledronsyre medac leveres som pakninger, der indeholder 1 flaske, eller som multipakninger med 4 eller 10 kartoner, der hver indeholder 1 flaske.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion
Danish: LÆGEMIDLETS NAVN Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning
English: Uncommon: Very rare:
Danish: Ikke almindelig: Meget sjælden:
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Zoledronsyre medac 4 mg/5 ml koncentrat til infusionsvæske, opløsning
English: How to store Zoledronic acid medac
Danish: Sådan skal du bruge Zoledronsyre medac
English: How Zoledronic acid medac is used
Danish: Zoledronsyre medac indeholder
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Danish: Zoledronsyre medac 4 mg/100 ml infusionsvæske, opløsning Zoledronsyre
English: Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 packs each containing 1 bottle.
Danish: Zoledronsyre medac leveres i pakninger, der indeholder 1 flaske, eller multipakninger bestående af 4 eller 10 pakninger, der hver indeholder 1 flaske.
English: 3.0 mg* *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Danish: Anbefalet dosis af zoledronsyre* 4,0 mg 3,5 mg* 3,3 mg* 3,0 mg* *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr=75 ml/min).
English: Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre medac 4 mg/5 ml koncentrat til infusionsvæske, opløsning, fortyndet yderligere i 100 ml (se pkt.
English: LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Danish: ETIKET PÅ MULTIPAKNINGER MED 10 HÆTTEGLAS PAKKET I TRANSPARENT FOLIE (INKLUSIVE ”BLÅ BOKS”)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/779/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/779/002
English: 0.5 mg/dl or 44 µmol/l;
Danish: (>1,4 mg/dl eller >124 μmol/l).
English: Hypersensitivity reaction Angioneurotic oedema
Danish: Angioneurotisk ødem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/779/004
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic acid medac.
Danish: Derudover har der været sporadiske rapporter om osteonekrose af andre steder, inklusive hoften og femur.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution.
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Danish: Zoledronsyre medac 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre
English: - Chest pain.
Danish: - Nældefeber.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 4 mg zoledronsyre (som monohydrat).
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Danish: Tabel 2: Resultater for virkning (patienter med prostatacancer i hormonbehandling)
English: Uveitis
Danish: Konfusion
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS CARTON FOR 1 VIAL AS PART OF A MULTIPACK COMPRISING 10 VIALS
Danish: KARTON TIL 1 HÆTTEGLAS SOM DEL AF EN MULTIPAKNING, DER INDEHOLDER 10 HÆTTEGLAS
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Danish: Tabel 3: Resultater for virkning (patienter med prostatacancer i hormonbehandling)
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 cartons each containing 1 vial.
Danish: Zoledronsyre medac leveres som enkeltpakninger, der indeholder 1 hætteglas eller 4 hætteglas, og som multipakninger med 4 eller 10 kartoner, der hver indeholder 1 hætteglas.
English: − For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of
Danish: (<1,4 mg/dl eller <124 μmol/l).
English: 1.0 mg/dl or 88 µmol/l.
Danish: - Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med unormal kreatinin ved baseline
English: Common: Uncommon:
Danish: Ikke almindelig:
English: Vomiting, nausea Abdominal pain
Danish: Opkastning, kvalme
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cardalis on 23 July 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cardalis den 23. juli 2012.
English: Other information about Cardalis:
Danish: Andre oplysninger om Cardalis:
English: It is available as chewable tablets (2.5 mg/20 mg, 5 mg/40 mg and 10 mg/80 mg).
Danish: Det fås som tyggetabletter (2,5 mg/20 mg, 5 mg/40 mg og 10 mg/80 mg).
English: A six month safety study was also conducted in Beagle dogs at up to five times the recommended dose.
Danish: Der blev desuden gennemført en seks måneders sikkerhedsundersøgelse hos Beagle-hunde med op til fem gange den anbefalede dosis.
English: This is a type of heart disease where the heart cannot pump enough blood around the body.
Danish: Det er en form for hjertesygdom, hvor hjertet ikke kan pumpe nok blod rundt i kroppen.
English: The safety study showed Cardalis to have a good safety profile.
Danish: Sikkerhedsundersøgelsen viste, at Cardalis har en god sikkerhedsprofil.
English: It must not be used in dogs intended or used for breeding.
Danish: Det må ikke anvendes hos hunde, som er beregnet til eller anvendes til opdræt.
English: The tablets may either be mixed with a small amount of food offered to the dog just before the main meal, or with the meal itself.
Danish: Tabletterne kan enten blandes med en lille mængde mad, som hunden får lige før hovedmåltidet eller sammen med hovedmåltidet.
English: The field study showed Cardalis to be voluntarily and fully consumed 92% of the time when offered with or without food and around 86% of dogs showed good compliance with treatment.
Danish: Feltundersøgelsen viste, at Cardalis blev frivilligt og fuldt ud indtaget 92% af tiden, når det blev givet med eller uden mad, og omkring 86% af hundene udviste en god tilpasning til behandlingen.
English: This allowed the existing field data on the single active substances to be applied to Cardalis.
Danish: Dette gjorde det muligt at anvende de eksisterende feltdata for de aktive enkeltstoffer på Cardalis.
English: Benazepril hydrochloride / spironolactone
Danish: Benazepril hydrochlorid/spironolacton
English: The main measure of effectiveness was good treatment compliance, which was defined as dogs consuming at least 90% of their tablets.
Danish: Det .vigtigste mål for effektivitet var en god tilpasning til behandlingen, hvilket blev defineret som hunde, der indtog mindst 90% af deres tabletter.
English: Spironolactone also works on the heart and blood vessels in other ways, although these mechanisms have not yet been fully demonstrated in dogs.
Danish: Spironolacton virker også på hjertet og blodkarrene i andre henseender, omend disse mekanismer endnu ikke er fuldt ud påvist hos hunde.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Danish: Dette reducerer den samlede blodmængde, hvilket mindsker det arbejde, som hjertet skal udføre for at pumpe blod, og forbedrer derved dets funktionsevne.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cardalis exceed the risks and recommended that be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Cardalis opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cardalis.
English: A field study was conducted in dogs to demonstrate how well Cardalis tablets were taken and how easy they were to give.
Danish: Der blev gennemført en feltundersøgelse for at påvise, hvor let Cardalis tabletter kunne tages, og hvor let de var at give.
English: The tablets are given to the dog once a day with food at a dose of 0.25 mg benazepril hydrochloride and 2 mg spironolactone per kilogram bodyweight.
Danish: Tabletterne gives til hunden en gang dagligt med mad ved en dosis på 0,25 mg benazepril hydrochlorid og 2 mg spironolacton pr. kilogram kropsvægt.
English: The company also presented the results of field studies with the individual active substances given as separate tablets, where the main measure of effectiveness was the number of dogs that died due to heart disease.
Danish: Firmaet fremviste også resultaterne af feltundersøgelser, hvor de enkelte aktive stoffer blev givet som separate tabletter, og hvor det vigtigste mål for effektivitet var det antal hunde, der døde som følge af hjertesygdom.
English: Kidney function and potassium levels in the blood should be monitored before start of treatment in all dogs.
Danish: Nyrefunktion og kaliumniveauer i blodet skal monitoreres, inden behandlingen påbegyndes hos alle hunde.
English: People with known hypersensitivity (allergy) to spironolactone or benazepril should avoid contact with Cardalis.
Danish: Personer med kendt overfølsomhed (allergi) over for spironolacton eller benazepril bør undgå kontakt med Cardalis.
English: By blocking aldosterone, spironolactone increases the elimination of salt and water in the urine.
Danish: Ved at blokere for aldosteron øger spironolacton eliminationen af salt og vand i urinen.
English: People should wash their hands after handling the tablets.
Danish: Enhver, der håndterer tabletterne, bør efterfølgende vaske hænder.
English: Cardalis is a veterinary medicine that contains two active substances, benazepril hydrochloride and spironolactone.
Danish: Cardalis er et veterinærlægemiddel, der indeholder to aktive stoffer, benazepril hydrochlorid og spironolacton.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Danish: Benazepril er et prodrug, dvs. et stof der konverteres til benazeprilat i kroppen.
English: What is the risk associated with Cardalis?
Danish: Hvilken risiko er der forbundet med Cardalis?
English: Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child.
Danish: Gravide kvinder skal være særligt opmærksomme på at undgå utilsigtet indtagelse, da ACE-hæmmere har vist sig at kunne påvirke det ufødte barn.
English: In the laboratory study, Cardalis was shown to be bioequivalent to combined treatment with products containing the single active substances (medicines are bioequivalent when they produce the same levels of active substance in the body).
Danish: I laboratorieundersøgelsen påvistes Cardalis at være bioækvivalent med kombineret behandling med produkter, som indeholdt de aktive enkeltstoffer (lægemidler er bioækvivalente, når de danner de samme mængder aktivt stof i kroppen).
English: Why has Cardalis been approved?
Danish: Hvorfor blev Cardalis godkendt?
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Danish: Når angiotensin IIproduktionen falder, afslappes og udvides blodkarrene.
English: Cardalis is used for congestive heart failure caused by long-term damage to the heart valves.
Danish: Cardalis anvendes til kongestiv hjerteinsufficiens forårsaget af langvarig beskadigelse af hjerteklapperne.
English: Spironolactone blocks the actions of aldosterone, a hormone that causes the kidneys to retain salt and water within the body with harmful effects on the cardiovascular system.
Danish: Spironolacton blokerer for virkningen af aldosteron, et hormon der får nyrerne til at holde på salt og vand i kroppen med skadelig indvirkning på det kardiovaskulære system.
English: These studies demonstrated an increased survival in dogs treated concurrently with spironolactone and benazepril compared to benazepril alone.
Danish: Disse undersøgelser påviste en øget overlevelse hos hunde, som samtidig fik behandling med spironolacton og benazepril, sammenlignet med benazepril alene.
English: The company presented a laboratory study in Beagle dogs comparing treatment with spironolactone and benazepril as single active substances (in the products Prilactone and Fortekor which are already authorised in the EU) to treatment with Cardalis.
Danish: Firmaet fremviste en laboratorieundersøgelse hos Beagle-hunde, hvor man sammenlignede behandling med spironolacton og benazepril som aktive enkeltstoffer (i produkterne Prilactone og Fortekor, der allerede er godkendt i EU) til behandling med Cardalis.
English: Cardalis is used to treat dogs with congestive heart failure.
Danish: Cardalis anvendes til behandling af hunde med kongestiv hjerteinsufficiens.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: ACE-hæmmere sænker produktionen af angiotensin II, en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: What is Cardalis?
Danish: Hvad er Cardalis?
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Danish: Benazeprilat er en "angiotensinkonverterende enzym-hæmmer (ACE-hæmmer)".
English: Non-castrated male dogs treated with spironolactone may show atrophy (wasting) of the prostrate (a gland of the male reproductive system) that is reversible.
Danish: Ikke-kastrerede hanhunde behandlet med spironolacton kan udvise atrofi (svind) af prostata (en kirtel i det mandlige reproduktive system), der er reversibel.
English: Cardalis should be used with caution in dogs with liver damage as this may alter the way spironolactone is metabolised (processed) in the liver.
Danish: Cardalis bør anvendes med forsigtighed hos hunde med leverskade, da dette kan ændre den måde, hvorpå spironolacton metaboliseres (bearbejdes) i leveren.
English: Regular monitoring should continue in dogs with reduced kidney function as they may have an increased risk of hyperkalaemia (raised potassium levels in the blood) during treatment.
Danish: Regelmæssig monitorering skal fortsætte hos hunde med reduceret nyrefunktion, da de kan have øget risiko for hyperkaliæmi (øgede kaliumniveauer i blodet) under behandlingen.
English: Cardalis should not be given to growing dogs due to its effect on male sex hormones.
Danish: Cardalis bør ikke gives til hunde i vækst, da stoffet påvirker de mandlige kønshormoner.
English: Cardalis must not be used in cases of aortic or pulmonary stenosis (narrowing of the aorta or pulmonary blood vessels) affecting the heart's blood output.
Danish: Cardalis bør ikke anvendes i tilfælde af aortastenose eller pulmonal stenose (forsnævring af aorta eller pulmonale blodkar), som påvirker hjertets output af blod.
English: Cardalis must not be used in pregnant or lactating (milk producing) bitches as toxic effects for the foetus were seen in studies of benazepril in rats.
Danish: Cardalis må ikke anvendes hos drægtige eller ammende (mælkeproducerende) tæver, da der konstateredes toksiske virkninger på fosteret ved undersøgelse af benazepril hos rotter.
English: It must not be used in dogs which are hypersensitive (allergic) to ACE inhibitors or to any of the ingredients.
Danish: Det må ikke gives til dyr, der er overfølsomme (allergiske) over for ACE-hæmmere eller andre af indholdsstofferne.
English: Cardalis must not be used in dogs with Addison's disease or hypoadrenocorticism (a condition where the adrenal gland does not produce sufficient amounts of hormones), hyperkalaemia (increased blood potassium levels) or hyponatraemia (reduced blood sodium levels).
Danish: Cardalis må ikke anvendes hos hunde med Addisons sygdom eller hypoadrenokorticisme (en sygdom, hvor binyren fremstiller for få hormoner), hyperkaliæmi (øget kaliumindhold i blodet) eller hyponatriæmi (mindsket natriumindhold i blodet).
English: How has Cardalis been studied?
Danish: Hvordan er Cardalis blevet undersøgt?
English: What is Cardalis used for?
Danish: Hvad anvendes Cardalis til?
English: What benefit has Cardalis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cardalis?
English: How does Cardalis work?
Danish: Hvordan virker Cardalis?
English: Lemtrada received a marketing authorisation valid throughout the EU on 12 September 2013.
Danish: Lemtrada fik en markedsføringstilladelse med gyldighed i hele EU den 12. september 2013.
English: 1 See outcome of safety review carried out in 2019.
Danish: 1 Se resultatet af sikkerhedsgennemgangen i 2019.
English: Other information about Lemtrada
Danish: Andre oplysninger om Lemtrada
English: Further information on Lemtrada can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lemtrada
Danish: Yderligere information om Lemtrada findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/lemtrada.
English: What is Lemtrada and what is it used for?
Danish: Hvad er Lemtrada, og hvad anvendes det til?
English: • disease that is highly active, even though they have been treated with a disease-modifying therapy;
Danish: • meget aktiv sygdom, selv om de har fået en sygdomsmodificerende behandling
English: Lemtrada is used for patients with:
Danish: Lemtrada anvendes til patienter med:
English: As for all medicines, data on the use of Lemtrada are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Lemtrada løbende overvåget.
English: An overview of Lemtrada and why it is authorised in the EU
Danish: En oversigt over Lemtrada, og hvorfor det er godkendt i EU
English: Lemtrada is given as an infusion (drip) into a vein over about 4 hours.
Danish: Lemtrada gives som en infusion (drop) i en blodåre over ca. 4 timer.
English: The Agency considered that studies have shown the benefit for patients with highly active disease and rapidly worsening severe disease.
Danish: Agenturet fandt, at studierne har vist en gavnlig virkning hos patienter med meget aktiv sygdom og hurtigt forværrende alvorlig sygdom.
English: What measures are being taken to ensure the safe and effective use of Lemtrada?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lemtrada?
English: Patients should receive certain medicines before or during treatment to reduce the side effects.
Danish: Patienterne skal have visse lægemidler før eller under behandlingen for at mindske bivirkningerne.
English: The company that markets Lemtrada will carry out studies on the safety of the medicine and to assess whether the medicine is used according to the latest recommendations.
Danish: Virksomheden, der markedsfører Lemtrada, skal gennemføre studier af lægemidlets sikkerhed og vurdere, om lægemidlet anvendes i overensstemmelse med de seneste anbefalinger.
English: The European Medicines Agency decided that Lemtrada's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Lemtrada opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Lemtrada authorised in the EU?
Danish: Hvorfor er Lemtrada godkendt i EU?
English: The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52.
Danish: Det aktive stof i Lemtrada, alemtuzumab, er en type protein, der kaldes et monoklonalt antistof, der er konstrueret til at binde sig til et andet protein, der kaldes CD52.