FrancophonIA/ELRC3.0 huggingface dataset:
English: The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Danish: Middeloverlevelsen blandt 135 patienter, der fik Nivolumab BMS, var ca. 9 måneder, hvorimod den blandt de 137 patienter, der fik docetaxel, var 6 måneder.
English: The active substance in Nivolumab BMS is a monoclonal antibody.
Danish: Det aktive stof i Nivolumab BMS er et monoklonalt antistof.
English: Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
Danish: Nivolumab BMS er sædvanligvis forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet på kroppens organer.
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms of side effects.
Danish: Virksomheden skal desuden udlevere et advarselskort til patienterne med oplysninger om risiciene ved lægemidlet samt anvisninger for, hvornår de skal kontakte lægen, hvis de får symptomer på bivirkninger.
English: Treatment with Nivolumab BMS was compared with another cancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients lived).
Danish: Behandling med Nivolumab BMS blev sammenlignet med et andet kræftlægemiddel, docetaxel, og hovedmålet for effektivitet var samlet overlevelse (hvor længe patienter levede).
English: Supportive information was also provided from another study indicating that Nivolumab BMS could produce a response in patients whose disease had progressed despite several previous treatments.
Danish: Underbyggende oplysninger blev også leveret fra et andet studie, der angav, at Nivolumab BMS kunne frembringe en respons hos patienter, hvis sygdom var fremskreden på trods af flere tidligere behandlinger.
English: Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Danish: Nivolumab BMS er et cancerlægemiddel, der anvendes til behandling af voksne med en type lungecancer, der kaldes planocellulært ikke-småcellet lungecancer (NSCLC).
English: Side effects were considered manageable with appropriate measures and were outweighed by the benefits.
Danish: Bivirkninger fandtes at være overskuelige ved passende forholdsregler og blev opvejet af
English: The antigen to which nivolumab has been designed to attach is a receptor called ‘programmed cell death-1' (PD-1), which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells.
Danish: Det antigen, som nivolumab er opbygget til at bindes til, er en receptor, kaldet "programmeret celledød-1" (PD-1), som slukker for aktiviteten af visse celler i immunsystemet (kroppens naturlige forsvar), kaldet T-celler.
English: For more information about treatment with Nivolumab BMS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nivolumab BMS, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), der er opbygget til at genkende og bindes til en specifik struktur (et antigen), der findes i visse celler i kroppen.
English: It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other cancer medicines (chemotherapy).
Danish: Det anvendes til patienter, hvis sygdom har spredt sig lokalt eller til andre dele af kroppen, og som tidligere er blevet behandlet
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nivolumab BMS, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nivolumab BMS, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Danish: Lægemidlet fås som et koncentrat til fremstilling af en opløsning til infusion (drop) i en vene.
English: What is Nivolumab BMS and what is it used for?
Danish: Hvad er Nivolumab BMS, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Nivolumab BMS.
Danish: Det er ikke en praktisk vejledning i, hvordan Nivolumab BMS bør anvendes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nivolumab BMS on 20.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
English: The medicine was associated with improved survival over docetaxel in patients with advanced, previously treated squamous NSCLC, a patient group who have few treatment options.
Danish: Lægemidlet blev forbundet med forbedret overlevelse i forhold til docetaxel hos patienter med fremskreden, tidligere behandlet planocellulært NSCLC, en patientgruppe, der har få behandlingsmuligheder.
English: Nivolumab BMS can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Danish: Nivolumab BMS udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge
English: For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Danish: Den fuldstændige liste over alle bivirkninger og begrænsninger ved Nivolumab BMS fremgår af
English: It will also conduct further studies on the long-term benefits of Nivolumab BMS, and try to identify which patients are most likely to benefit from treatment with the medicine.
Danish: Virksomheden skal derudover gennemføre yderligere studier over de langsigtede fordele ved Nivolumab samt prøve at udpege de patienter, der mest sandsynligt forventes at få gavn af behandling med lægemidlet.
English: The recommended dose is 3 mg of nivolumab per kilogram body weight given into a vein over 60 minutes, every two weeks for as long as the patient continues to benefit from it. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Danish: Den anbefalede dosis er 3 mg nivolumab pr. kg kropsvægt givet i en vene over 60 minutter hver anden uge, så længe patienten responderer positivt på den.
English: What are the risks associated with Nivolumab BMS?
Danish: Hvilke risici er der forbundet med Nivolumab BMS?
English: Nivolumab BMS have been shown to improve patients' survival in one main study involving 272 patients with previously treated squamous NSCLC that was advanced or had spread throughout the body.
Danish: Det er blevet påvist i ét hovedstudie, der involverede 272 patienter med tidligere behandlet planocellulært NSCLC, der var fremskreden eller havde spredt sig til hele kroppen, at Nivolumab BMS havde forbedret patienternes overlevelse.
English: What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv
English: What benefits of Nivolumab BMS have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nivolumab BMS?
English: How does Nivolumab BMS work?
Danish: Hvordan virker Nivolumab BMS?
English: Most will resolve following appropriate treatment or on stopping Nivolumab BMS.
Danish: De fleste bivirkninger svinder ved passende behandling eller ved ophør
English: In addition, the company that markets Nivolumab BMS will provide educational packs for doctors who are expected to prescribe the medicine, containing information on how it should be used and how to manage side effects, particularly side effects related to the activity of the immune system.
Danish: Desuden skal den virksomhed, der markedsfører Nivolumab BMS, udlevere oplysningsmateriale til læger, der forventes at ordinere lægemidlet.
English: nivolumab
Danish: De nærmere oplysninger fremgår af
English: Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
Danish: 15 ml (20 mg/ml) 1 hætteglas
English: 300mg Concentrate for solution for infusion
Danish: 300 mg Koncentrat til infusionsvæske, opløsning
English: EMA procedure number
Danish: EMA's procedurenr.
English: (Invented) name Strength
Danish: (Særnavn) Navn Styrke
English: These effects are usually reversible.
Danish: Disse virkninger er sædvanligvis reversible.
English: This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Danish: Dette er den indikation, som ansøgeren nu foreslår, og som er blevet registreret i 15 medlemsstater i EU.
English: Not known: (cannot be estimated from the available data)
Danish: Ikke kendt: (kan ikke estimeres ud fra forhåndenværende data)
English: Clinical and biological monitoring is required.
Danish: Klinisk og biologisk monitorering er påkrævet.
English: The clinical consequences of these interactions have not been evaluated.
Danish: De kliniske konsekvenser af disse interaktioner er ikke blevet evalueret.
English: Use in children and adolescents (< 18 years)
Danish: Børn og unge (<18 år)
English: Patients should be rehydrated before the administration.
Danish: Patienterne bør rehydreres før administration.
English: Limited data are available in regard to overdosage in humans.
Danish: Begrænsede data er tilgængelige med hensyn til overdosering hos mennesker.
English: This effect is thought to be a result of the complimentary actions of both components.
Danish: Denne virkning menes at være resultatet af komplementære mekanismer hos begge komponenter.
English: Treatment is symptomatic and supportive.
Danish: Behandling bør være symptomatisk og understøttende.
English: • if you are, think you may be or are planning to become pregnant (see also “Pregnancy and breast-feeding”)
Danish: • hvis De er gravid, tror De kan være gravid eller planlægger at blive gravid (se også "Graviditet og amning")
English: Use in the elderly Dosage adjustment is not usually necessary for the elderly.
Danish: Ældre Dosisjustering er normalt ikke nødvendigt hos ældre.
English: Therefore the CHMP considered that this indication is acceptable.
Danish: CHMP var derfor af den opfattelse, at denne indikation kan accepteres.
English: At least 61 percent of the oral dose is eliminated unchanged within 24 hours.
Danish: Mindst 61% af den orale dosis udskilles uændret i løbet af 24 timer.
English: They may cause fetal electrolyte disturbances and possibly other reactions that have been observed in adults.
Danish: De kan medføre føtale elektrolytforstyrrelser og muligvis andre reaktioner, som er blevet observeret hos voksne.
English: Germany VARIPHARM ARZNEIMITTEL GMBH
Danish: Tyskland VARIPHARM ARZNEIMITTEL GMBH
English: In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.
Danish: Generelt opnås den antihypertensive virkning inden for 3-4 uger efter initiering af behandling.
English: The volume of distribution of losartan is 34 liters.
Danish: Losartans fordelingsvolumen er 34 liter.
English: • if you are on a salt-restricted diet
Danish: • hvis De er på saltbegrænset diæt
English: These patients (9.4%) would have been over-treated on a FDC on a long term basis.
Danish: Disse patienter (9,4 %) ville være blevet overbehandlet med fastdosiskombinationen over lang tid.
English: The adverse events below are classified where appropriate by system organ class and frequency according to the following convention:
Danish: Bivirkningerne nedenfor er klassificeret, hvor dette er hensigtsmæssigt, i henhold til systemorganklasser og frekvens i overensstemmelse med følgende konvention: Meget almindelig:
English: You should not take Cozaar Comp in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
Danish: De bør ikke tage Cozaar Comp. i de første 12 uger af graviditeten, og De må overhovedet ikke tage det efter 13. uge, da brug under graviditet kan være skadeligt for barnet.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR COMP. AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF COZAAR COMP. OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The following side effects have been reported:
Danish: Følgende bivirkninger er set:
English: If symptomatic hypotension should occur, supportive treatment should be instituted.
Danish: Hvis symptomatisk hypotension skulle opstå, bør understøttende behandling indsættes.
English: When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.
Danish: Når De starter behandling med denne medicin, bør De ikke udføre opgaver, som kræver særlig opmærksomhed (f.eks. køre bil eller betjene farlige maskiner), indtil De ved, hvordan medicinen påvirker Dem.
English: Common: Insomnia
Danish: Almindelig: Insomnia.
English: In case of an overdose, contact your doctor immediately so that medical attention may be given promptly.
Danish: I tilfælde af en overdosis skal De kontakte lægen omgående, så De kan få hurtig lægehjælp.
English: This medicinal product is authorized in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Belgien
English: - the CHMP concluded that the data are not supportive of the following indications and therefore they should be removed from the marketing authorisation:
Danish: - CHMP konkluderede, at dataene ikke understøtter følgende indikationer, som derfor skal fjernes fra markedsføringstilladelsen:
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indication:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for den følgende indikation:
English: - The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Danish: - De produktresuméer, den etikettering og indlægsseddel, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på grundlag af den fremlagte dokumentation og den faglige drøftelse i udvalget.
English: There is no experience in children and adolescents.
Danish: Der er ingen erfaring med behandling af børn og unge.
English: 75114 Paris Cedex 08 France
Danish: 75114 Paris Cedex 08
English: Other antihypertensive drugs Additive effect.
Danish: Andre antihypertensiva Additiv virkning.
English: Most older patients require the same dose as younger patients.
Danish: De fleste ældre personer har brug for samme dosis som yngre.
English: The active metabolite is 10- to 40-times more active than losartan on a weight for weight basis.
Danish: Den aktive metabolit er 10-40 gange mere aktiv end losartan på vægtbasis.
English: High Blood Pressure
Danish: Forhøjet blodtryk
English: Laboratory Test Interactions
Danish: Laboratorietestinteraktioner
English: Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients.
Danish: Periodisk bestemmelse af serumelektrolytter bør udføres med passende intervaller hos sådanne patienter.
English: 28027 MADRID
Danish: 28027 MADRID, Spanien
English: Skanstes street 13, LV-1013, Riga, Latvia
Danish: Skanstes street 13, LV-1013, Riga, Letland
English: Do not use Cozaar Comp after the expiry date which is stated on the container.
Danish: Brug ikke Cozaar Comp. efter den udløbsdato, der står på pakningen.
English: 00191 Rome, Italy
Danish: 00191 Rom, Italien
English: In clinical studies of at least one year's duration, the antihypertensive effect was maintained with continued therapy.
Danish: I kliniske undersøgelser af mindst 1 års varighed holdt den antihypertensive virkning sig ved fortsat behandling.
English: No specific information is available on the treatment of overdosage with Cozaar Comp.
Danish: Der findes ingen specifik information vedrørende behandling af overdosering med Cozaar Comp.
English: • Swelling of the face, fever.
Danish: • Hævelse af ansigtet, feber.
English: If you experience the following, stop taking Cozaar Comp tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Danish: Hvis De oplever følgende, skal De stoppe med at tage Cozaar Comp. og straks fortælle lægen om det eller tage på skadestuen på det nærmeste hospital:
English: some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure)
Danish: nogle antibakterielle stoffer, f.eks. cotrimoxazol, spørg lægen hvis De er i tvivl om hvad det er).
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), Denmark notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Danish: På baggrund af divergerende nationale beslutninger, som medlemsstaterne havde taget vedrørende godkendelsen af ovennævnte produkter (og tilknyttede navne), indbragte Danmark i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, sagen for CHMP/EMEA's sekretariat for at udrede afvigelser mellem de nationalt godkendte produktresuméer og dermed harmonisere produkternes divergerende produktresuméer i hele EU.
English: After the discontinuation of losartan,PRA and angiotensin II values fell within 3 days to the baseline values.
Danish: Efter seponering af losartan faldt PRA og angiotensin-II-værdierne inden for tre dage til værdierne ved baseline.
English: The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Danish: Mekanismen bag den antihypertensive virkning af thiaziddiuretika er ukendt.
English: Sector 1, Bucureşti
Danish: Sector 1, Bukarest, Rumænien
English: There was no relevant difference in the number of patients with severe hypertension showing a relevant BP lowering effect during the first 4 weeks.
Danish: Der var ingen betydelig forskel i antallet af patienter med svær hypertension, som opnåede en relevant blodtrykssænkende virkning i løbet af de første fire uger.
English: Given that the paediatric worksharing group is still ongoing, a definite working can only be implemented with respecto to studies in children and adolescents after the procedure is finalised.
Danish: Da den pædiatriske arbejdsgruppe stadig er i gang, kan en endelig ordlyd med hensyn til undersøgelser af børn og unge først implementeres, når proceduren er afsluttet.
English: In addition, a prevention indication for HCTZ alone, based on the LIFE data is not considered approvable.
Danish: Endvidere kan en indikation for hydrochlorthiazid alene som forebyggelse baseret på data fra LIFE ikke godkendes.
English: The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) should be amended to include the outcome of the PhVWP report on ACE Inhibitors and angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007).
Danish: CHMP var af den opfattelse, at produktresuméets tekst om graviditet og amning (afsnit 4.3, 4.4 og 4.6) skal ændres, så den omfatter resultatet af PhVWP-rapporten om ACE-hæmmere og angiotensin II-receptorantagonister (AIIRA'er) og anbefalinger om anvendelse i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007).
English: If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage should be adjusted accordingly.
Danish: Hvis calciumtilskud skal ordineres, skal serumcalciumkoncentrationen monitoreres, og calciumdoseringen bør justeres tilsvarende.
English: Losartan has no effect on autonomic reflexes and no sustained effect on plasma norepinephrine.
Danish: Losartan har ingen virkning på autonome reflekser og ingen vedvarende virkning på noradrenalin i plasma.
English: • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking Losartan potassium and Hydrochlorothiazide tablets.
Danish: • hvis De skal have bedøvelse (også hos tandlægen), eller De skal opereres, eller hvis De skal have foretaget prøver af parathyroideafunktionen, skal De fortælle Deres læge eller sundhedspersonalet, at De tager losartankalium og hydrochlorthiazid tabletter
English: • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
Danish: • hvis De har forsnævring af arterierne (atherosclerose), angina pectoris (smerter i brystet pga dårlig hjertefunktion)
English: Taking Cozaar Comp with food and drink
Danish: Brug af Cozaar Comp. sammen med mad og drikke
English: More than 50% of those patients reaching the target BP on the FDC within 4 weeks did not require a combination.
Danish: Mere end 50 % af de patienter, der nåede målblodtrykket med fastdosiskombinationen inden for fire uger, havde ikke behov for en kombinationsbehandling.
English: Renal transplantation There is no experience in patients with recent kidney transplantation.
Danish: Nyretransplantation Der er ingen erfaring med patienter, der for nylig er nyretransplanteret.
English: Furthermore, losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin.
Danish: Desuden hæmmer losartan ikke ACE (kininase II), enzymet som nedbryder bradykinin.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.
Danish: Forværring eller aktivering af systemisk lupus erythematosus er rapporteret i forbindelse med behandling med thiazider.
English: • if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus).
Danish: • hvis De har eller har haft en allergisk tilstand, astma eller en tilstand som kan medføre ledsmerter, hududslæt og feber (systemisk lupus erythematosus)
English: Generally losartan causes a decrease in serum uric acid (usually <0.4 mg/dL) which was persistent in chronic therapy.
Danish: Generelt gav losartan et fald i serumurinsyre (sædvanligvis <0,4 mg/dl), som var vedvarende ved kronisk terapi.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis lægen har fortalt Dem, at der er visse sukkerarter, De ikke kan tåle, skal De kontakte Deres læge, før De tager denne medicin.
English: The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Danish: Den mest sandsynlige manifestation ved overdosering vil være hypotension og takykardi; bradykardi kan opstå af parasympatisk (vagus) stimulation.
English: Both losartan and its principal active metabolite have a far greater affinity for the AT1 receptor than for the AT2 receptor.
Danish: Både losartan og dets primære aktive metabolit har meget større affinitet over for AT1-receptoren end over for AT2-receptoren.
English: It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Danish: Det er vigtigt at fortsætte med at tage Cozaar Comp., så længe lægen foreskriver det, da det vil sikre en jævn kontrol af Deres blodtryk.