FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Olanzapine Glenmark, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olanzapine Glenmark, olanzapin, er et antipsykotisk lægemiddel.
English: Olanzapine Glenmark is a medicine containing the active substance olanzapine.
Danish: Olanzapine Glenmark er et lægemiddel, som indeholder det aktive stof olanzapin.
English: The Committee recommended that Olanzapine Glenmark be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Olanzapine Glenmark.
English: Because Olanzapine Glenmark is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Olanzapine Glenmark er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Olanzapine Glenmark is a ‘generic medicine'.
Danish: Olanzapine Glenmark er et »generisk lægemiddel«.
English: Because Olanzapine Glenmark is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine Zyprexa.
Danish: Da Olanzapine Glenmark er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Zyprexa.
English: Olanzapine Glenmark olanzapine
Danish: Olanzapine Glenmark olanzapin
English: Other information about Olanzapine Glenmark
Danish: Andre oplysninger om Olanzapine Glenmark
English: What are the benefits and risks of Olanzapine Glenmark?
Danish: Hvilken fordel og risiko er der forbundet med Olanzapine Glenmark?
English: Why has Olanzapine Glenmark been approved?
Danish: Hvorfor blev Olanzapine Glenmark godkendt?
English: What is Olanzapine Glenmark?
Danish: Hvad er Olanzapine Glenmark?
English: How has Olanzapine Glenmark been studied?
Danish: Hvordan blev Olanzapine Glenmark undersøgt?
English: What is Olanzapine Glenmark used for?
Danish: Hvad anvendes Olanzapine Glenmark til?
English: How is Olanzapine Glenmark used?
Danish: Hvordan anvendes Olanzapine Glenmark?
English: How does Olanzapine Glenmark work?
Danish: Hvordan virker Olanzapine Glenmark?
English: Yes.
Danish: Ja.
English: Frequently asked questions
Danish: Ofte stillede spørgsmål
English: Did you know?
Danish: Vidste du det?
English: Patients' organisations in your country may also be able to help.
Danish: Patientorganisationerne i dit land kan muligvis også hjælpe.
English: Are my personal data protected?
Danish: Er mine personlige oplysninger beskyttet?
English: We are always learning more about medicines.
Danish: Vi lærer hele tiden mere om lægemidler.
English: What information should I report?
Danish: Hvilke oplysninger skal jeg indberette?
English: What happens to my report after I've sent it?
Danish: Hvad sker der med min indberetning, når jeg har sendt den?
English: If possible, you should provide the following information when making your report:
Danish: Så vidt muligt skal du give følgende oplysninger, når du indberetter:
English: Your report is used solely for the scientific evaluation of the medicine.
Danish: Din indberetning bliver udelukkende anvendt til den videnskabelige vurdering af lægemidlet.
English: You can also check the publicly available European database (www.adrreports.eu) or contact your national medicines authority for further information.
Danish: Du kan også se efter i den europæiske data-base (www.adrreports.eu) eller kontakte de nationale lægemiddelmyndigheder for at få flere oplysninger.
English: The symbol does not mean that your medicine is unsafe.
Danish: Trekanten betyder ikke, at lægemidlet ikke er sikkert at anvende.
English: All personal information related to the reporting of a side effect is processed in accordance with EU data protection legislation.
Danish: Alle personlige oplysninger, der gives i forbindelse med indberetning af en bivirkning, bliver behandlet efter EU's lovgivning om beskyttelse af oplysninger.
English: A side effect (also called an adverse reaction) is an unwanted symptom or effect caused by a medicine.
Danish: En bivirkning (også kaldet en uønsket reaktion) er et uønsket symptom eller en uønsket virkning, der forårsages af et lægemiddel.
English: Although they are tested extensively in clinical trials before they are authorised, not everything can be known about their side effects until they have been used by many people over time.
Danish: Selv om lægemidler afprøves grundigt i kliniske undersøgelser inden de godkendes, kan man ikke vide alt om deres bivirkninger, før de efterhånden har været brugt af mange mennesker.
English: Remember to speak to your doctor or pharmacist if you are worried about any suspected side effects.
Danish: Husk at tale med lægen eller apotekspersonalet, hvis du er bekymret over formodede bivirkninger.
English: You can also report a side effect on behalf of someone in your care, such as a child or relative.
Danish: Du kan også indberette en bivirkning på vegne af en, du tager dig af - et barn eller et familiemedlem.
English: Where can I find information on side effects that have already been reported with the medicine?
Danish: Hvor kan jeg finde oplysninger om bivirkninger, der i forvejen er indberet-tet med lægemidlet?
English: The inverted black triangle symbol '▼' serves as a reminder to report any suspected side effects, either because the medicine is new or because there is a particular need to find out more about its long-term safety.
Danish: Den omvendte sorte trekan '▼' skal minde om at indberette eventuelle formodede bivirkninger, enten fordi lægemidlet er nyt, eller fordi der er særligt behov for at finde ud af mere om dets sikkerhed ved langvarig brug.
English: As a patient, you have the right to report unwanted side effects of medicines directly to the authorities.
Danish: Som patient har du ret til at indberette bivirkninger ved lægemidler direkte til myndighederne.
English: • any other medicines being taken around the same time (including non-prescription medicines,
Danish: • eventuelle andre lægemidler, der er taget på omtrent samme tidspunkt (også håndkøbsmedicin,
English: After evaluating the safety signal and all other relevant data, medicines authorities may issue new warnings or advice on how the medicine should be used, and can even stop its use.
Danish: Når lægemiddelmyndighederne har vurderet sikkerhedssignalet og al anden relevant information, vil de muligvis udsende nye advarsler eller anvisninger for lægemidlets brug, og de kan også standse brugen af det.
English: You should contact them immediately if you have a side effect that you think is serious or that is listed as serious in the package leaflet that comes with your medicine.
Danish: Du skal straks kontakte dem, hvis du får bivirkninger, som du mener er alvorlige, eller som er fremhævet som alvorlige i den indlægsseddel, der følger med lægemidlet.
English: You cannot always be certain that what you are experiencing is caused by the medicine, but by reporting suspected side affects you can help the authorities in their investigations, which will lead to safer medicines.
Danish: Du kan ikke altid være sikker på, at det du kommer ud for, skyldes læ-gemidlet, men ved at indberette formodede bivirkninger hjælper du myndighederne med deres under-søgelser, og det vil føre til sikrere lægemidler.
English: • the batch number of the medicine (found on the packaging);
Danish: • batchnummeret på lægemidlet (“lot”, står på emballagen)
English: Your doctor or pharmacist can help you complete your report, and you can also request that they send the report on your behalf.
Danish: Lægen eller apotekspersonalet kan hjælpe dig med at udfylde indberetningen, og du kan også få dem til at sende den ind for dig.
English: herbal remedies and contraceptives);
Danish: urtemedicin og svangerskabsforebyggende midler)
English: • the dose and the name of the medicine suspected to have caused the side effect (brand name as well as active ingredient);
Danish: • dosis af og navn på det lægemiddel, der formodes at have givet bivirkningen (både handelsnavn og aktivt indholdsstof)
English: • information on the person who has had the side effect (such as age and sex);
Danish: • oplysninger om den person, der har fået bivirkningen (alder og køn)
English: You can report side effects yourself
Danish: Du kan selv indberette bivirkninger
English: • any other health conditions that the person who experienced the side effect may have.
Danish: • eventuelle andre lidelser hos den person, der fik bivirkningen.
English: • the description of the side effect;
Danish: • beskrivelse af bivirkningen
English: Can I get help with reporting a side effect?
Danish: Kan jeg få hjælp til at indberette en bivirkning?
English: You can check the package leaflet that comes with the medicine.
Danish: Du kan læse indlægssedlen, der følger med lægemidlet.
English: Why report a side effect?
Danish: Hvorfor indberette en bivirkning?
English: How do I know I've experienced a side effect?
Danish: Hvordan kan jeg vide, at jeg har fået en bivirkning?
English: If you are worried about any suspected side effects from your medicine, please speak to your doctor or pharmacist for advice.
Danish: Hvis du er bekymret over formodede bivirkninger, skal du rådføre dig med lægen eller apotekspersona-let.
English: You can usually report side effects by filling in a form online or from your doctor or local pharmacy.
Danish: Du kan enten udfylde den online eller få den udleveret af lægen eller på apoteket.
English: If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.
Danish: Mener du, at et lægemiddel har forårsaget en bivirkning, skal du se efter i indlægssedlen, der følger med lægemidlet.
English: For more details, and to report online, please check the website of your national authority (use these links to ensure you are reporting to the appropriate website).
Danish: For at få flere oplysninger og indberette online, skal du besøge webstedet for den nationale myndighed i dit land.
English: How do I report a side effect?
Danish: Hvordan indberetter jeg en bivirkning?
English: By reporting side effects, you can help to provide more information about medicines, which will ultimately help to make them safer.
Danish: Ved at indberette bivirkninger kan du være med til at skaffe flere oplysninger om lægemidler.
English: Your report, along with other reports on the medicine, will be reviewed by medicines safety experts to see if there is any new information (known as a 'safety signal').
Danish: De vil undersøge, om der er tale om nye oplysninger (“sikkerhedssignaler”).
English: The medicine has a black triangle symbol in its package leaflet.
Danish: Hvad betyder det, hvis der er en sort trekant på lægemidlets indlægsseddel?
English: The capsules should be taken with food, preferably at the same time every day.
Danish: Kapslerne skal tages sammen med mad og helst på samme tid hver dag.
English: This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.
Danish: Dette lægemiddel er identisk med Urorec, der har været godkendt i EU siden den 29. januar 2010.
English: In two of the studies the IPSS was around 21 points at the start of the study.
Danish: I to af studierne lå IPSS på ca. 21 point ved begyndelsen af studiet.
English: This may be increased to 8 mg once a day after a week.
Danish: Dosen kan øges til 8 mg en gang dagligt efter en uge.
English: When enlarged, it can cause problems with the flow of urine.
Danish: Når den er forstørret, kan det give problemer med urinstrømmen.
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Danish: Til mænd med moderate nyreproblemer bør startdosen på være 4 mg en gang dagligt.
English: Further information on Silodosin Recordati can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
Danish: Yderligere information om Silodosin Recordati findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
English: The recommended dose is one 8 mg capsule once a day.
Danish: Den anbefalede dosis er én 8-mg-kapsel én gang dagligt.
English: The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist.
Danish: Det aktive stof i Silodosin Recordati, silodosin, er en alfa-adrenoreceptor-antagonist.
English: For more information about using Silodosin Recordati, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Silodosin Recordati, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg).
Danish: Silodosin Recordati udleveres kun efter recept og fås som kapsler (4 mg og 8 mg).
English: The symptoms were measured using the international prostate symptom score (IPSS).
Danish: Symptomerne blev målt ved hjælp af den internationale prostatasymptomscore (IPSS).
English: Silodosin Recordati is not recommended for patients with severe kidney problems.
Danish: Silodosin Recordati anbefales ikke til patienter med svære nyreproblemer.
English: As for all medicines, data on the use of Silodosin Recordati are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Silodosin Recordati løbende overvåget.
English: Side effects reported with Silodosin Recordati are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Silodosin Recordati vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: IFIS is a condition that makes the iris floppy.
Danish: IFIS er en tilstand, som gør pupillen slap.
English: The European Medicines Agency therefore decided that Silodosin Recordati's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Silodosin Recordati opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo (a dummy treatment).
Danish: Efter 12 uger faldt IPSS med 6,4 point hos de mænd, som tog Silodosin Recordati, sammenholdt med 3,5 point hos de mænd, der tog placebo (en uvirksom behandling).
English: It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Danish: Det virker ved at blokere nogle receptorer (mål) kaldet alfa1A-adrenoreceptorer, som findes i blærehalskirtlen, blæren og urinrøret (som går fra blæren og ud af kroppen).
English: The most common side effect with Silodosin Recordati (which may affect more than 1 in 10 people) is a reduction in the amount of semen released during ejaculation.
Danish: De hyppigste bivirkninger ved Silodosin Recordati (som optræder hos mere end 1 ud af 10 patienter) er en reduktion i mængden af sæd, som frigøres under ejakulation.
English: In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.
Danish: I et tredje studie lå IPSS på ca. 19 point inden behandlingen og faldt med 7 point med Silodosin Recordati sammenholdt med 6,7 point hos mænd, som tog tamsulosin (et andet lægemiddel for godartet forstørrelse af blærehalskirtlen) og 4,7 point med placebo.
English: Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.
Danish: Tre hovedstudier med mere end 1.800 mænd viste, at Silodosin Recordati var effektivt til at mindske symptomerne på godartet forstørrelse af blærehalskirtlen, f.eks. problemer med vandladningen.
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Danish: Når disse receptorer er aktiveret, får de de muskler, der styrer urinstrømmen, til at trække sig sammen.
English: What measures are being taken to ensure the safe and effective use of Silodosin Recordati?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Silodosin Recordati?
English: An overview of Silodosin Recordati and why it is authorised in the EU
Danish: En oversigt over Silodosin Recordati, og hvorfor det er godkendt i EU
English: Other information about Silodosin Recordati
Danish: Andre oplysninger om Silodosin Recordati
English: Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class.
Danish: Silodosin Recordati er effektivt til at mindske vandladningsproblemer hos mænd med godartet forstørrelse af blærehalskirtlen, og bivirkningerne svarer til bivirkningerne ved andre lægemidler i samme klasse.
English: Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Danish: Silodosin Recordati er et lægemiddel, der anvendes til behandling af symptomerne på godartet forstørrelse af blærehalskirtlen (prostatahyperplasi, BPH) hos voksne.
English: What is Silodosin Recordati and what is it used for?
Danish: Hvad er Silodosin Recordati, og hvad anvendes det til?
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Danish: Ved at blokere disse receptorer får silodosin disse muskler til at slappe af, hvilket gør det lettere at lade vandet og mindsker symptomerne på godartet forstørrelse af blærehalskirtlen.
English: The prostate gland is an organ found at the base of the bladder in men.
Danish: Blærehalskirtlen er et organ, som sidder nederst i blæren hos mænd.
English: For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Silodosin Recordati fremgår af indlægssedlen.
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Danish: Hos nogle patienter, som tager alfa-adrenoreceptor-antagonister, kan der opstå intraoperativt floppy-iris-syndrom (IFIS), og dette kan medføre komplikationer under operationer for grå stær.
English: Why is Silodosin Recordati authorised in the EU?
Danish: Hvorfor blev Silodosin Recordati godkendt i EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silodosin Recordati have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Silodosin Recordati.
English: What are the risks associated with Silodosin Recordati?
Danish: Hvilke risici er der forbundet med Silodosin Recordati?
English: What benefits of Silodosin Recordati have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Silodosin Recordati?
English: How is Silodosin Recordati used?
Danish: Hvordan anvendes Silodosin Recordati?
English: How does Silodosin Recordati work?
Danish: Hvordan virker Silodosin Recordati?
English: Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler, der indeholder aminocapronsyre, og som har markedsføringstilladelse i Den Europæiske Union Medlemsstat
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: Fortegnelse over lægemidlernes særnavne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 2500 mg/10 ml
Danish: Epsicaprom 25 2500 mg/10 ml
English: Member State (EU/EEA)
Danish: EU/EAA
English: ROTTAPHARM, S.L.
Danish: ES - Spanien ROTTAPHARM, S.L.
English: solution for injection
Danish: Injektionsvæske, opløsning Intravenøs anvendelse
English: Diagonal 67-69 08019 Barcelona España
Danish: 08019 Barcelona
English: ES - Spain
Danish: España
English: However, no special considerations are needed in this population.
Danish: Specielle hensyn er imidlertid ikke nødvendige hos denne population.
English: • At request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: The effect at 12 months was consistent in most subgroups.
Danish: Virkningen ved 12 måneder var konsistent i de fleste delgrupper.
English: This effect was maintained up to Month 24.
Danish: Denne effekt var vedligeholdt op til måned 24.
English: Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016
Danish: Dato for første markedsføringstilladelse: 22. januar 2007 Dato for seneste fornyelse: 11. november 2016
English: Elderly (age 65 years and over)
Danish: Ældre (65 år og derover)
English: • performed or planned intraocular surgery within the previous or next 28 days.
Danish: • Udførte eller planlagte intraokulære operationer inden for de foregående eller næste 28 dage.
English: Comparative control up to Month 3.
Danish: Komparativ kontrol op til måned 3.
English: 30-Jun-2020
Danish: 30juni-2020
English: The apparent systemic half-life was approximately 6 days.
Danish: Den tilsyneladende systemiske halveringstid var ca. 6 dage.
English: 2870 Puurs Belgium
Danish: 2870 Puurs Belgien
English: Two different pack types are available:
Danish: Der er to forskellige pakningstyper tilgængelige;
English: However, evidence of reversibility was observed after recovery.
Danish: Der sås imidlertid tegn på reversibilitet efter restitution.
English: Populations with limited data
Danish: Populationer med begrænset data
English: Re-use may lead to infection or other illness/injury.
Danish: Genbrug kan medføre infektion eller andre sygdomme/skader.
English: Group III vPDT
Danish: Gruppe III vPDT
English: Systemic clearance was slightly lower, but this was not clinically significant.
Danish: Den systemiske clearance var lidt lavere, men dette var ikke klinisk signifikant.
English: • Aggressive posterior (AP)-ROP
Danish: • Aggressiv posterior (AP)-ROP
English: Bilateral treatment
Danish: Bilateral behandling
English: Final study report:
Danish: Endelig studierapport:
English: No dose adjustment is required in the elderly.
Danish: Dosisjustering er ikke påkrævet hos ældre.
English: In these diseases, Lucentis can help to stabilise and in many cases improve your vision.
Danish: Ved disse sygdomme kan Lucentis hjælpe til at stabilisere, og i mange tilfælde forbedre, dit syn.
English: For other subscales of this questionnaire no treatment differences could be established.
Danish: For andre af dette spørgeskemas underskalaer kunne der ikke fastslås en behandlingsforskel.
English: The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of:
Danish: Dosis bør tilbageholdes, og behandlingen bør ikke genoptages tidligere end den næste fastsatte behandling, i følgende tilfælde:
English: b p-value for pairwise comparison is one-sided.
Danish: b p-værdi for den parvise sammenligning er ensidet.
English: Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection.
Danish: Nogle patienter vil måske kun have behov for én injektion i de første 12 måneder, mens andre kan have behov for hyppigere behandling, herunder injektion hver måned.
English: These posterior segment changes diminished, and in some instances resolved, during the recovery period.
Danish: Disse forandringer i det bageste segment mindskedes og svandt i nogle tilfælde i løbet af restitutionsperioden.