FrancophonIA/ELRC3.0 huggingface dataset:
English: Median values for baseline characteristics were: age 37 years, disease duration 6.7 years, and EDSS score 2.0.
Danish: Medianværdien for karakteristika ved udgangspunktet var: alder 37 år, sygdommens gennemsnitlige varighed 6,7 år og EDS score 2,0.
English: OUTER CARTON OF MULTIPACK CONTAINING WALLETS (WITH BLUE BOX)
Danish: YDERKARTON FOR MULTIPAKNING INDEHOLDENDE ETUIER (INKL.
English: Exposure to the sun and protection against the sun Fingolimod weakens your immune system.
Danish: Fingolimod svækker dit immunsystem.
English: o Women of child-bearing potential, including adolescent females, their parents (or legal representatives), and caregivers, should be counselled before treatment initiation and regularly thereafter about the serious risks of GILENYA to the foetus, facilitated by the pregnancy-specific patient reminder card.
Danish: Fertile kvinder alder, herunder unge kvinder, skal: o Informeres inden opstart af behandling og derefter regelmæssigt af deres læge om Gilenya's alvorlige risici for fosteret og om kontraindikationen til gravide kvinder og fertile kvinder, der ikke anvender effektiv kontraception.
English: Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related cancer, has been reported in patients treated with Gilenya.
Danish: Der er der rapporteret tilfælde af infektion med human papilloma virus (HPV) infektion, herunder godartet knude (papillom), celleforandring (dysplasi), vorter og HPV-relateret kræft, hos patienter behandlet med Gilenya.
English: BLISTERS FOR UNIT PACK
Danish: BLISTER FOR ENKELTPAKNING
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Danish: Titandioxid (E 171) Gul jernoxid (E 172)
English: Specialised pre-natal monitoring will be performed.
Danish: Der vil blive lavet specialiserede undersøgelser på dit ufødte barn (prænatal undersøgelse).
English: Some side effects could be or could become serious Common (may affect up to 1 in 10 people): - Coughing with phlegm, chest discomfort, fever (signs of lung disorders) - Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning,
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): - Hoste med slim, ubehag i brystet, feber (tegn på lungesygdom) - Herpes-virusinfektion (helvedesild eller herpes zoster) med symptomer, som fx vabler, svie,
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to switch to non heart-ratelowering therapy or, if not possible, to determine appropriate monitoring.
Danish: Hvis behandling med Gilenya overvejes til disse patienter, skal de forventede fordele opveje de mulige risici, og der skal søges rådgivning hos en kardiolog om skift til en behandling, som ikke sænker hjertefrekvensen, eller hvis dette ikke er muligt for at fastlægge passende monitorering.
English: o Women of childbearing potential must use effective contraception during treatment and for two months following treatment discontinuation.
Danish: o Fertile kvinder skal anvende effektiv kontraception under behandlingen og i to måneder efter seponering af Gilenya-behandling.
English: Median (mean) number of new or enlarging T2 lesions over 24 months
Danish: Median (middel) antal nye eller forstørrrede T2læsioner i løbet af 24 måneder
English: - Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV
Danish: - Patienter med 2. grads Mobitz type II-atrioventrikulær (AV) blok, 3. grads AV-blok eller syg sinussyndrom, hvis de ikke har en pacemaker (se pkt.
English: If used during pregnancy, Gilenya can harm the unborn baby.
Danish: Der er risiko for at skade det ufødte barn, hvis Gilenya tages under graviditet.
English: • Cardiac monitoring guidance;
Danish: • Vejledning for hjertemonitorering;
English: Rare cases of tumefactive lesions associated with MS relapse were reported in the post-marketing setting.
Danish: Der er efter markedsføring blevet rapporteret om sjældne tilfælde af tumefaktive læsioner forbundet med MR-attakker.
English: Gilenya 0.25 mg hard capsules - Each capsule contains 0.25 mg fingolimod (as hydrochloride).
Danish: Gilenya 0,25 mg hårde kapsler - Hver kapsel indeholder 0,25 mg fingolimod (som hydrochlorid).
English: Gilenya 0.5 mg hard capsules - Each capsule contains 0.5 mg fingolimod (as hydrochloride).
Danish: Gilenya 0,5 mg hårde kapsler - Hver kapsel indeholder 0,5 mg fingolimod (som hydrochlorid).
English: Median (mean) number of new or enlarging T2 lesions over 12 months
Danish: Median (middel) antal nye eller forstørrede T2læsioner i løbet af 12 måneder
English: Cases of cutaneous T-cell lymphoma (mycosis fungoides) have been observed.” and under the section 2 of the PL “A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with Gilenya”.
Danish: 2 i indlægssedlen ”En type cancer i lymfesystemet (lymfom) er blevet rapporteret hos MS-patienter behandlet med Gilenya”.
English: If Gilenya is used during pregnancy, there is a risk of harm to the unborn baby.
Danish: Gilenya kan skade det ufødte barn, hvis det tages under graviditet.
English: When stopping fingolimod therapy for planning a pregnancy the possible return of disease activity should be considered (see section 4.4).
Danish: Muligheden for tilbagevendende sygdomsaktivitet skal tages i betragtning, når behandlingen med fingolimod seponeres for at planlægge graviditet (se pkt.
English: During treatment, patients receiving Gilenya should be instructed to report promptly symptoms of infection to their physician.
Danish: Patienterne skal instrueres i straks at rapportere symptomer på infektion til deres læge under behandlingen.
English: If treatment with Gilenya is considered in such patients, advice from a cardiologist should be sought regarding the switch to non heart-rate lowering medicinal products or appropriate monitoring for treatment initiation, at least overnight monitoring is recommended, if the heart-rate-lowering medication cannot be stopped.
Danish: Hvis behandling med Gilenya overvejes til disse patienter, bør der søges rådgivning hos en kardiolog vedrørende skift til lægemidler, der ikke sænker hjertefrekvensen, eller om hensigtsmæssig monitorering under behandlingsstart.
English: Median values for baseline characteristics were: age 36 years, disease duration 5.9 years, and EDSS score 2.0.
Danish: Medianværdier for karakteristika ved údgangspunktet var: alder 36 år, sygdomsvarighed 5,9 år, og EDSS 2,0.
English: What Gilenya is and what it is used for What you need to know before you take Gilenya How to take Gilenya
Danish: Det skal du vide, før du begynder at tage Gilenya Sådan skal du tage Gilenya Bivirkninger
English: Gilenya 0.25 mg hard capsules Gilenya 0.5 mg hard capsules
Danish: Gilenya 0,25 mg hårde kapsler Gilenya 0,5 mg hårde kapsler
English: Mannitol
Danish: Dimeticon
English: stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4).
Danish: - Patienter, som i de foregående 6 måneder har haft myokardieinfarkt (MI), ustabil angina pectoris, slagtilfælde/transitorisk iskæmisk anfald (TIA), dekompenseret hjertesvigt (behandlingskrævende) eller New York Heart Association (NYHA) klasse III/IV-hjertesvigt (se pkt.
English: Patients with hypertension uncontrolled by medication were excluded from participation in premarketing clinical trials and special care is indicated if patients with uncontrolled hypertension are treated with Gilenya.
Danish: Patienter med hypertension, som ikke var medicinsk kontrolleret, blev ekskluderet fra deltagelse i kliniske studier udført før markedsføring.
English: Gilenya 0.5 mg hard capsules
Danish: Gilenya 0,5 mg hårde kapsler
English: Gilenya 0.25 mg hard capsules Gilenya 0.5 mg hard capsules fingolimod
Danish: Gilenya 0,25 mg hårde kapsler Gilenya 0,5 mg hårde kapsler fingolimod
English: Gilenya 0.25 mg hard capsules
Danish: Gilenya 0,25 mg hårde kapsler
English: One capsule contains 0.5 mg fingolimod (as hydrochloride).
Danish: En kapsel indeholder 0,5 mg fingolimod (som hydrochlorid).
English: Concomitant administration with St. John's Wort is however not recommended (see section 4.4).
Danish: Samtidig indgivelse af perikon kan dog ikke anbefales (se pkt.
English: stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure; o Severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III
Danish: York Heart Association (NYHA) klasse III/IV-hjertesvigt i de foregående 6 måneder o Alvorlig hjertearytmi, der kræver anti-arytmisk behandling med klasse Ia- eller klasse III
English: Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride).
Danish: Hver 0,25 mg kapsel indeholder 0,25 mg fingolimod (som hydrochlorid).
English: INTERMEDIATE CARTON OF MULTIPACK - WALLET (WITHOUT BLUE BOX)
Danish: DELPAKNING I MULTIPAKNING - ETUI (EKSKL.
English: If the heart-rate-lowering medication cannot be stopped, cardiologist's advice should be sought to determine appropriate first dose monitoring, at least overnight extended monitoring is recommended (see also section 4.5).
Danish: Hvis medicinen, som sænker hjertefrekvensen, ikke kan seponeres, skal der søges rådgivning hos en kardiolog for at fastlægge passende monitorering efter første dosis.
English: Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride).
Danish: Hver 0,5 mg hård kapsel indeholder 0,5 mg fingolimod (som hydrochlorid).
English: Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for 2 months after treatment discontinuation (see sections 4.3 and 4.6 and the information contained in the Physician Information Pack).
Danish: Der skal foreligge en negativ graviditetstest, og der skal anvendes effektiv kontraception under behandling og i 2 måneder efter seponering (se pkt.
English: On initiation of Gilenya treatment it is recommended that patients be observed for a period of 6 hours (see section 4.4, Bradyarrhythmia).
Danish: Det anbefales derfor, at observere patienterne i 6 timer ved initiering af behandling med Gilenya (se pkt.
English: One capsule contains 0.25 mg fingolimod (as hydrochloride).
Danish: En kapsel indeholder 0,25 mg fingolimod (som hydrochlorid).
English: • wearing appropriate protective clothing.
Danish: • Gå med tøj, der beskytter dig mod solens stråler.
English: Vascular disorders
Danish: Vaskulære tilstande
English: GILENYA 0.5 mg hard capsules fingolimod
Danish: GILENYA 0,5 mg hårde kapsler fingolimod
English: Magnesium stearate
Danish: Kapselindhold Mannitol Magnesiumstearat
English: Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related cancer, has been reported under treatment with fingolimod in the post-marketing setting.
Danish: Efter markedsføring er der rapporteret tilfælde af human papilloma virus (HPV) infektion, herunder papillom, dysplasi, vorter og HPV-relateret kræft, under behandling med fingolimod.
English: Regarding lymphoma, the MAH proposed to update the section 4.4 of the SmPC regarding the risk of lymphoma “There have been cases of lymphoma in clinical studies and the post-marketing setting.
Danish: 4.4 i produktresuméet vedrørende risikoen for lymfom.
English: GILENYA 0.25 mg hard capsules fingolimod
Danish: GILENYA 0,25 mg hårde kapsler fingolimod
English: Physician's checklist for adult and pediatric patients, to consider prior to prescribing GILENYA, including information about the Pregnancy Exposure Registry; The Patient / Parent / Caregiver's guide, to be provided to all patients, their parents (or legal representatives), and caregivers.
Danish: Lægers tjekliste for voksne og pædiatriske patienter til orientering inden ordination af Gilenya, inklusiv information om the Pregnancy Exposure Registry.
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported at the 0.5 mg dose in clinical trials and in the post-marketing setting (see section 4.8).
Danish: Der er i kliniske studier og efter markedsføring rapporteret sjældne tilfælde af posterior reversibelt encefalopati-syndrom (PRES) (se pkt.
English: • Depression and anxiety are known to occur with increased frequency in the multiple sclerosis population and have been reported also in pediatric patients treated with GILENYA;
Danish: Depression og angst er ligeledes indberettet hos pædiatriske patienter, som blev behandlet med Gilenya;
English: - If you experience convulsions or fits before or whilst taking Gilenya, let your doctor know.
Danish: - Fortæl det til lægen, hvis du oplever kramper eller krampeanfald, før eller når du tager Gilenya.
English: Repeat the first dose monitoring after the second dose of GILENYA; o Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients:
Danish: o Forlæng hjertefrekvens-monitorering på sygehus mindst natten over, og indtil tilstanden er ophørt, hos patienter:
English: - if you are taking or have recently taken medicines that slow your heart rate (such as beta blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesteratic agents or pilocarpine).
Danish: verapamil, diltiazem eller ivabradin, digoxin, kolinesterasehæmmere eller pilocarpin).
English: Merkel cell carcinoma*** Blood and lymphatic system disorders Common:
Danish: Blod og lymfesystem Almindelig:
English: Lung problems
Danish: Lungeproblemer
English: Gilenya 0.5 mg hard capsules have a white opaque body and bright yellow opaque cap. “FTY0.5mg” is imprinted on the cap with black ink and two bands are imprinted on the body with yellow ink.
Danish: Gilenya 0,5 mg hårde kapsler har en hvid, uigennemsigtig underdel og en klar gul, uigennemsigtig overdel.
English: Bradyarrhythmia
Danish: Bradykardi
English: Seizure
Danish: Rygsmerter
English: anti-arrhythmic medicinal products; o Second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not wear a pacemaker; o Patients with a baseline QTc interval ≥500 msec; o Pregnant women and women of childbearing potential not using effective contraception; o Hypersensitivity to the active substance or to any of the excipients.
Danish: o 2. grads Mobitz type II-atrioventrikulær (AV) blok, 3. grads AV-blok eller syg sinussyndrom, hvis de ikke har en pacemaker.
English: Pregnancy-specific patient reminder card
Danish: Patientkort rettet specifikt mod graviditet
English: Blood count
Danish: BLUE BOX)
English: Concomitant administration with St John's wort is not recommended (see section 4.5).
Danish: Samtidig indgivelse af perikon frarådes (se pkt.
English: • Liver function should be monitored at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter; the approved dosing of 0.5 mg daily (or 0.25 mg once daily in pediatric patients 10 years of age and above with a body weight of ≤40 kg) should be administered.
Danish: Den godkendte dosis på 0,5 mg dagligt (eller 0,25 mg en gang dagligt hos pædiatriske patienter på 10 år eller derover og med en kropsvægt ≤40 kg) skal benyttes.
English: The physician information should contain the following key messages:
Danish: Informationen til lægerne bør indeholde de følgende essentielle beskeder:
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Danish: • Muligheden for at inkludere patienterne i registreringsundersøgelsen, for at facilitere indsamlingen af data for virkning og sikkerhed på langt sigt;
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sørge for at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som beskrives nedenunder, implementeres:
English: • The need to monitor patients for changes in their lipid profiles;
Danish: • Behovet for at overvåge patienterne for ændringer i deres lipidprofiler;
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Danish: • Den identificerede og mulige risiko for immunogenicitet, der kan føre til immunmedierede symptomer;
English: • The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
Danish: • Behov for at instruere patienter i korrekt teknik til selvadministration, når patienten indvilliger i og er i stand til at gøre dette, og retningslinjer for sundhedspersonale om hvordan administrationsfejl skal indberettes;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Danish: • Sundhedspersonalets behov for at udføre en årlig klinisk vurdering af patienterne, med hensyn til en mulig forhøjet risiko for udvikling af maligniteter;
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with ARCALYST;
Danish: • Risiko for svære infektioner, herunder opportunistiske bakterielle og virale infektioner samt svampeinfektioner hos patienter, der blev behandlet med Arcalyst;
English: • The risk of acute injection-related reactions;
Danish: • Risiko for akutte injektionsrelaterede reaktioner;
English: • The unknown safety of ARCALYST in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Danish: • Den ukendte sikkerhed af Arcalyst hos gravide og ammende kvinder, som dermed medfører at lægerne skal diskutere denne risiko med patienterne, hvis de bliver gravide eller hvis de planlægger at blive gravide;
English: • The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving ARCALYST as treatment with ARCALYST should not be initiated in patients with neutropenia;
Danish: • Behovet for at udføre neutrofiltal før behandlingen påbegyndes, efter 1-2 måneder og derefter periodevist, mens der gives Arcalyst, da behandling med Arcalyst ikke bør påbegyndes hos patienter med neutropeni;
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use ARCALYST are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sørge at alle læger, som forventes at ordinere/anvende Arcalyst skal forsynes med en lægelig informationspakke før lancering, som indeholder det følgende:
English: • Physician information
Danish: • Information til lægerne
English: Use at the same time each day.
Danish: Bruges på samme tid hver dag.
English: Adults, including the elderly
Danish: Voksne inklusive ældre personer
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 24 September 2012
Danish: Dato for første markedsføringstilladelse: 11. december 2007 Dato for seneste fornyelse: 24. september 2012
English: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Danish: Der er ikke observeret nogen generelle forskelle i sikkerhed og virkning mellem ældre og yngre patienter.
English: You can usually carry on using the drops, unless you experience serious side effects.
Danish: Du kan som regel fortsætte med at bruge dråberne, medmindre du får alvorlige bivirkninger.
English: - if you have had repeated eye surgery within a short period of time.
Danish: - Hvis du har gennemgået flere øjenoperationer inden for en kortere periode.
English: Date of first authorisation: 03 May 2013
Danish: Dato for første markedsføringstilladelse: 3. maj 2013
English: Do not give this medicine to children and adolescents below 18 years old because the safety and efficacy in this population has not been established.
Danish: Dette lægemiddel må ikke anvendes til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos denne befolkningsgruppe.
English: An additional drop should be administered 30 to 120 minutes prior to surgery.
Danish: Der bør dryppes en ekstra dråbe 30 til 120 minutter før operation.
English: How to use Wash your hands before you start.
Danish: Vask dine hænder, inden du begynder.
English: The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data).
Danish: Nedenstående bivirkninger er klassificeret i henhold til følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - if you have diabetes.
Danish: - Hvis du har sukkersyge (diabetes).
English: Rare: cutis laxa (dermatochalasis), allergic dermatitis
Danish: Sjælden: Cutis laxa (dermatokalasi), allergisk dermatitis
English: Interactions mediated by protein binding are also unlikely.
Danish: Interaktioner, der medieres ved proteinbinding, er også usandsynlig.
English: Then use it for as long as your doctor tells you to.
Danish: Derefter skal du bruge det så længe, som din læge har ordineret.
English: They may increase the risk of bleeding.
Danish: Disse kan øge risikoen for blødning.
English: Continue on the day of surgery.
Danish: Fortsæt på operationsdagen.
English: Nepafenac has not been evaluated in long-term carcinogenicity studies.
Danish: Nepafenac er ikke blevet evalueret i long-term karcinogenicitetsstudier.
English: Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor.
Danish: Patienterne bør derfor instrueres om ikke at bære kontaktlinser, medmindre det er klart angivet af deres læge.
English: These findings indicate rapid corneal penetration.
Danish: Disse resultater tyder på hurtig penetrering af cornea.
English: The bottle may be presented in a pouch.
Danish: Flasken kan være anbragt i en pose.
English: However, efficacy beyond day 14 post operation was not measured.
Danish: Virkningen ud over 14 dage efter operationen blev ikke målt.
English: If you use drops in both eyes, repeat the steps for your other eye.
Danish: Hvis du bruger dråber i begge øjne, skal du gentage trinnene for det andet øje.
English: • Gently press on the base of the bottle to release one drop of NEVANAC at a time.
Danish: • Tryk let på flaskens bund for at frigøre en dråbe NEVANAC ad gangen.
English: It is not necessary to close and shake the bottle between administrations for both eyes.
Danish: Det er ikke nødvendigt at lukke og ryste flasken mellem drypning af det ene og det andet øje.
English: In vitro, the percent bound to rat albumin, human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively.
Danish: In vitro var procentdelen bundet til rottealbumin, humant albumin og humant serum, henholdsvis 98,4 %, 95,4 % og 99,1 %.
English: Additionally, nearly all patients received prophylactic treatment with antibiotics, according to clinical practice at each of the clinical trial sites.
Danish: Desuden modtog næsten samtlige patienter profylaktisk behandling med antibiotika i overensstemmelse med klinisk praksis på de kliniske centre.
English: Inflammation clearing and pain free rates were similar for both products at all postoperative evaluations.
Danish: Helbredelse af inflammation og smertefrihed var sammenlignelige for begge produkter ved alle postoperative evalueringer.
English: Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely.
Danish: Interaktioner, der involverer CYP-medieret metabolisme af lægemidler, som administreres samtidig, er derfor usandsynlig.