natgillin/translations-raw huggingface dataset:
o Nødvendigheden af oftalmologisk vurdering af patienter med diabetes mellitus eller med uveitis i anamnesen under Gilenya-behandling.
o The need for ophthalmological assessment during treatment with GILENYA in patients with diabetes mellitus or with a history of uveitis.
o At der skal optages baseline-ekg og måles blodtryk før den første dosis af Gilenya (eller hvis sidste dosis blev administreret for mere end 2 uger siden).
o That they will have a baseline ECG and blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago).
o Påkrævet monitorering ved behandlingsstart Inden første dosis o Optag baseline-ekg før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden).
o Monitoring requirements at treatment initiation Before first dose o Perform baseline ECG prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
o Nødvendigheden af straks at indberette ethvert tegn på nedsat syn til den ordinerende læge under behandlingen og i op til to måneder efter, behandling med Gilenya er stoppet.
o The need to report any symptoms of visual impairment immediately to the prescriber during and for up to two months after the end of treatment with GILENYA.
o Foretag blodtryksmåling før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden).
o Perform blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
o At Gilenya er teratogent, og derfor skal kvinder i den frugtbare alder: o Være testet negative for graviditet.
o That GILENYA is teratogenic so women with childbearing potential must: o Have a negative pregnancy test. o Be using effective contraception during and for at least two months following discontinuation of treatment with GILENYA.
Dette øger immunsystemets evne til at dræbe kræftceller.
This increases the ability of the immune system to kill cancer cells.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Nivolumab BMS findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Nivolumab BMS can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lægemidlet indeholder det aktive stof nivolumab.
The medicine contains the active substance nivolumab.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nivolumab BMS.
This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Der er udarbejdet en risikostyringsplan for at sikre, at Nivolumab BMS anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Når nivolumab bindes til PD-1, blokerer det receptoren og hindrer den i at slukke for disse immunceller.
When it attaches to PD-1, nivolumab blocks the receptor and prevents it from switching off these immune cells.
De hyppigste bivirkninger ved Nivolumab BMS (som optræder hos mere end 1 ud af 10 personer) er træthed, nedsat appetit og kvalme (utilpashed), der i de fleste tilfælde er milde eller moderate.
The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Patienter, hvis cancer klart udtrykte PD-1, synes at drage størst nytte, men da andre patienter også responderede, er yderligere studier nødvendige for at afklare, hvilke patientgrupper der mest sandsynligt drager nytte af lægemidlet.
Patients whose cancer clearly expressed PD-1 seem to show most benefit, but as other patients also responded, further study to clarify patient groups most likely to benefit from the medicine is needed.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Nivolumab BMS opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS's benefits are greater than its risks and recommended that it be approved for use in the EU.
Middeloverlevelsen blandt 135 patienter, der fik Nivolumab BMS, var ca. 9 måneder, hvorimod den blandt de 137 patienter, der fik docetaxel, var 6 måneder.
The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Det aktive stof i Nivolumab BMS er et monoklonalt antistof.
The active substance in Nivolumab BMS is a monoclonal antibody.
Nivolumab BMS er sædvanligvis forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet på kroppens organer.
Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
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.
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.
Behandling med Nivolumab BMS blev sammenlignet med et andet kræftlægemiddel, docetaxel, og hovedmålet for effektivitet var samlet overlevelse (hvor længe patienter levede).
Treatment with Nivolumab BMS was compared with another cancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients lived).
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.
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.
Nivolumab BMS er et cancerlægemiddel, der anvendes til behandling af voksne med en type lungecancer, der kaldes planocellulært ikke-småcellet lungecancer (NSCLC).
Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Bivirkninger fandtes at være overskuelige ved passende forholdsregler og blev opvejet af
Side effects were considered manageable with appropriate measures and were outweighed by the benefits.
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.
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.
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.
For more information about treatment with Nivolumab BMS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
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.
Det anvendes til patienter, hvis sygdom har spredt sig lokalt eller til andre dele af kroppen, og som tidligere er blevet behandlet
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).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nivolumab BMS, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
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.
Lægemidlet fås som et koncentrat til fremstilling af en opløsning til infusion (drop) i en vene.
The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Hvad er Nivolumab BMS, og hvad anvendes det til?
What is Nivolumab BMS and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Nivolumab BMS bør anvendes.
It is not intended to provide practical advice on how to use Nivolumab BMS.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
The European Commission granted a marketing authorisation valid throughout the European Union for Nivolumab BMS on 20.
Lægemidlet blev forbundet med forbedret overlevelse i forhold til docetaxel hos patienter med fremskreden, tidligere behandlet planocellulært NSCLC, en patientgruppe, der har få behandlingsmuligheder.
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.
Nivolumab BMS udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge
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.
Den fuldstændige liste over alle bivirkninger og begrænsninger ved Nivolumab BMS fremgår af
For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
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.
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.
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.
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.
Hvilke risici er der forbundet med Nivolumab BMS?
What are the risks associated with Nivolumab BMS?
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.
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv
What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
Hvilke fordele viser undersøgelserne, at der er ved Nivolumab BMS?
What benefits of Nivolumab BMS have been shown in studies?
Hvordan virker Nivolumab BMS?
How does Nivolumab BMS work?
De fleste bivirkninger svinder ved passende behandling eller ved ophør
Most will resolve following appropriate treatment or on stopping Nivolumab BMS.
Desuden skal den virksomhed, der markedsfører Nivolumab BMS, udlevere oplysningsmateriale til læger, der forventes at ordinere lægemidlet.
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.
De nærmere oplysninger fremgår af
nivolumab
15 ml (20 mg/ml) 1 hætteglas
Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
300 mg Koncentrat til infusionsvæske, opløsning
300mg Concentrate for solution for infusion
EMA's procedurenr.
EMA procedure number
(Særnavn) Navn Styrke
(Invented) name Strength
Disse virkninger er sædvanligvis reversible.
These effects are usually reversible.
Dette er den indikation, som ansøgeren nu foreslår, og som er blevet registreret i 15 medlemsstater i EU.
This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Ikke kendt: (kan ikke estimeres ud fra forhåndenværende data)
Not known: (cannot be estimated from the available data)
Klinisk og biologisk monitorering er påkrævet.
Clinical and biological monitoring is required.
De kliniske konsekvenser af disse interaktioner er ikke blevet evalueret.
The clinical consequences of these interactions have not been evaluated.
Børn og unge (<18 år)
Use in children and adolescents (< 18 years)
Patienterne bør rehydreres før administration.
Patients should be rehydrated before the administration.
Begrænsede data er tilgængelige med hensyn til overdosering hos mennesker.
Limited data are available in regard to overdosage in humans.
Denne virkning menes at være resultatet af komplementære mekanismer hos begge komponenter.
This effect is thought to be a result of the complimentary actions of both components.
Behandling bør være symptomatisk og understøttende.
Treatment is symptomatic and supportive.
• hvis De er gravid, tror De kan være gravid eller planlægger at blive gravid (se også "Graviditet og amning")
• if you are, think you may be or are planning to become pregnant (see also “Pregnancy and breast-feeding”)
Ældre Dosisjustering er normalt ikke nødvendigt hos ældre.
Use in the elderly Dosage adjustment is not usually necessary for the elderly.
CHMP var derfor af den opfattelse, at denne indikation kan accepteres.
Therefore the CHMP considered that this indication is acceptable.
Mindst 61% af den orale dosis udskilles uændret i løbet af 24 timer.
At least 61 percent of the oral dose is eliminated unchanged within 24 hours.
De kan medføre føtale elektrolytforstyrrelser og muligvis andre reaktioner, som er blevet observeret hos voksne.
They may cause fetal electrolyte disturbances and possibly other reactions that have been observed in adults.
Tyskland VARIPHARM ARZNEIMITTEL GMBH
Germany VARIPHARM ARZNEIMITTEL GMBH
Generelt opnås den antihypertensive virkning inden for 3-4 uger efter initiering af behandling.
In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.
Losartans fordelingsvolumen er 34 liter.
The volume of distribution of losartan is 34 liters.
• hvis De er på saltbegrænset diæt
• if you are on a salt-restricted diet
Disse patienter (9,4 %) ville være blevet overbehandlet med fastdosiskombinationen over lang tid.
These patients (9.4%) would have been over-treated on a FDC on a long term basis.
Bivirkningerne nedenfor er klassificeret, hvor dette er hensigtsmæssigt, i henhold til systemorganklasser og frekvens i overensstemmelse med følgende konvention: Meget almindelig:
The adverse events below are classified where appropriate by system organ class and frequency according to the following convention:
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.
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.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF COZAAR COMP. OG TILKNYTTEDE NAVNE (SE BILAG I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR COMP. AND ASSOCIATED NAMES (SEE ANNEX I)
Følgende bivirkninger er set:
The following side effects have been reported:
Hvis symptomatisk hypotension skulle opstå, bør understøttende behandling indsættes.
If symptomatic hypotension should occur, supportive treatment should be instituted.
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.
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.
Almindelig: Insomnia.
Common: Insomnia
I tilfælde af en overdosis skal De kontakte lægen omgående, så De kan få hurtig lægehjælp.
In case of an overdose, contact your doctor immediately so that medical attention may be given promptly.
Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Belgien
This medicinal product is authorized in the Member States of the EEA under the following names:
- CHMP konkluderede, at dataene ikke understøtter følgende indikationer, som derfor skal fjernes fra markedsføringstilladelsen:
- the CHMP concluded that the data are not supportive of the following indications and therefore they should be removed from the marketing authorisation:
- CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for den følgende indikation:
- the CHMP concluded that the Marketing Authorisation could be harmonised on the following indication:
- 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.
- 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.
Der er ingen erfaring med behandling af børn og unge.
There is no experience in children and adolescents.
75114 Paris Cedex 08
75114 Paris Cedex 08 France
Andre antihypertensiva Additiv virkning.
Other antihypertensive drugs Additive effect.
De fleste ældre personer har brug for samme dosis som yngre.
Most older patients require the same dose as younger patients.
Den aktive metabolit er 10-40 gange mere aktiv end losartan på vægtbasis.
The active metabolite is 10- to 40-times more active than losartan on a weight for weight basis.
Forhøjet blodtryk
High Blood Pressure
Laboratorietestinteraktioner
Laboratory Test Interactions
Periodisk bestemmelse af serumelektrolytter bør udføres med passende intervaller hos sådanne patienter.
Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients.
28027 MADRID, Spanien
28027 MADRID
Skanstes street 13, LV-1013, Riga, Letland
Skanstes street 13, LV-1013, Riga, Latvia
Brug ikke Cozaar Comp. efter den udløbsdato, der står på pakningen.
Do not use Cozaar Comp after the expiry date which is stated on the container.
00191 Rom, Italien
00191 Rome, Italy
I kliniske undersøgelser af mindst 1 års varighed holdt den antihypertensive virkning sig ved fortsat behandling.
In clinical studies of at least one year's duration, the antihypertensive effect was maintained with continued therapy.
Der findes ingen specifik information vedrørende behandling af overdosering med Cozaar Comp.
No specific information is available on the treatment of overdosage with Cozaar Comp.
• Hævelse af ansigtet, feber.
• Swelling of the face, fever.
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:
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:
nogle antibakterielle stoffer, f.eks. cotrimoxazol, spørg lægen hvis De er i tvivl om hvad det er).
some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure)
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.
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.
Efter seponering af losartan faldt PRA og angiotensin-II-værdierne inden for tre dage til værdierne ved baseline.
After the discontinuation of losartan,PRA and angiotensin II values fell within 3 days to the baseline values.
Mekanismen bag den antihypertensive virkning af thiaziddiuretika er ukendt.
The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Sector 1, Bukarest, Rumænien
Sector 1, Bucureşti
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.
There was no relevant difference in the number of patients with severe hypertension showing a relevant BP lowering effect during the first 4 weeks.
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.
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.
Endvidere kan en indikation for hydrochlorthiazid alene som forebyggelse baseret på data fra LIFE ikke godkendes.
In addition, a prevention indication for HCTZ alone, based on the LIFE data is not considered approvable.
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).
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).
Hvis calciumtilskud skal ordineres, skal serumcalciumkoncentrationen monitoreres, og calciumdoseringen bør justeres tilsvarende.
If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage should be adjusted accordingly.
Losartan har ingen virkning på autonome reflekser og ingen vedvarende virkning på noradrenalin i plasma.
Losartan has no effect on autonomic reflexes and no sustained effect on plasma norepinephrine.
• 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
• 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.
• hvis De har forsnævring af arterierne (atherosclerose), angina pectoris (smerter i brystet pga dårlig hjertefunktion)
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
Brug af Cozaar Comp. sammen med mad og drikke
Taking Cozaar Comp with food and drink