FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ganfort findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Ganfort
Danish: Andre oplysninger om Ganfort
English: What measures are being taken to ensure the safe and effective use of Ganfort?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ganfort?
English: Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma.
Danish: Der er blevet gennemført fire hovedundersøgelser, der omfattede 1 964 voksne med okulær hypertension eller glaukom.
English: Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only.
Danish: Ganfort nedsatte trykket til mindre end 18 mmHg hos 18,7 % af disse patienter sammenlignet med 10,2 % med bimatoprost alene.
English: For more information about treatment with Ganfort, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ganfort, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ganfort.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ganfort skal anvendes.
English: Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening.
Danish: Ganfort gives som én dråbe i det berørte øje/de berørte øjne enten om morgenen eller om aftenen.
English: Ganfort must not be used in patients who have asthma or severe lung disease, or in patients with some heart conditions.
Danish: Ganfort må ikke anvendes til patienter med astma eller alvorlige lungelidelser eller til patienter med visse hjertelidelser.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Danish: Kombinationen af de to aktive stoffer har en additiv virkning og nedsætter trykket i øjet mere end de enkelte lægemidler alene.
English: Raised pressure in the eye causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Danish: Forhøjet tryk i øjet medfører beskadigelse af retina (den lysfølsomme membran bagest i øjet) og den optiske nerve, der sender signaler fra øjet til hjernen.
English: Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
Danish: Ganfort er øjendråber, opløsning, der indeholder to aktive stoffer, nemlig bimatoprost (0,3 mg/ml) og timolol (5 mg/ml).
English: The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ganfort opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Ganfort.
English: By lowering the pressure, Ganfort reduces the risk of damage.
Danish: Ved at nedsætte trykket reducerer Ganfort risikoen for beskadigelse.
English: The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range).
Danish: Virkningen blev hovedsagelig målt på den gennemsnitlige mindskning af tryk i øjet eller antallet af patienter, hvis tryk i øjet faldt til under målet på 18 mmHg (hvilket er inden for normalområdet).
English: Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone.
Danish: Ganfort var dog mere effektivt end bimatoprost til behandling af patienter, hvis tryk i øjet ikke kunne kontrolleres med øjendråber, som kun indeholdt prostaglandiner.
English: In addition, Ganfort was shown to be as effective as bimatoprost and timolol given at the same time.
Danish: Yderligere viste Ganfort sig at være lige så effektivt som bimatoprost og timolol givet samtidig.
English: What is the risk associated with Ganfort?
Danish: Hvilken risiko er der forbundet med Ganfort?
English: The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment.
Danish: I undersøgelserne blev Ganfort sammenlignet med bimatoprost, timolol eller bimatoprost og timolol givet samtidig efter behandling i mellem tre uger og fire måneder.
English: Ganfort was more effective than timolol on its own and was as effective as bimatoprost.
Danish: Ganfort var mere effektivt end timolol alene og lige så effektivt som bimatoprost.
English: Ganfort is used to reduce the pressure inside the eye.
Danish: Ganfort anvendes til at nedsætte trykket i øjet.
English: The most common side effect (seen in more than 1 patient in 10) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye).
Danish: Den hyppigste bivirkning (som optræder hos flere end 1 ud af 10 patienter) er konjunktival hyperæmi (øget blodtilførsel til øjet, hvilket gør øjnene røde).
English: In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%).
Danish: Flere patienter, som fik Ganfort, oplevede desuden et fald i trykket på mere end 20 % (67,9 % mod
English: It is used in adults with ‘open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Danish: Det anvendes til voksne med "åbenvinklet glaukom" eller "okulær hypertension", som responderer utilstrækkeligt på øjendråber, der indeholder betablokkere eller prostaglandinanaloger (andre lægemidler til behandling af disse lidelser).
English: Why has Ganfort been approved?
Danish: Hvorfor blev Ganfort godkendt?
English: For the full list of all side effects reported with Ganfort, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ganfort fremgår af indlægssedlen.
English: What is Ganfort?
Danish: Hvad er Ganfort?
English: Overall, the studies showed that Ganfort is effective in lowering eye pressure.
Danish: Alt i alt viste undersøgelserne, at Ganfort effektivt nedsætter trykket i øjet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ganfort 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 Ganfort.
English: How has Ganfort been studied?
Danish: Hvordan blev Ganfort undersøgt?
English: ‘Ocular hypertension' is when the pressure in the eye is higher than normal.
Danish: "Okulær hypertension" er unormalt højt tryk i øjet.
English: Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s.
Danish: Timolol har været almindeligt anvendt til behandling af glaukom (grøn stær) siden 1970'erne.
English: How is Ganfort used?
Danish: Hvordan anvendes Ganfort?
English: What benefit has Ganfort shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ganfort?
English: What is Ganfort used for?
Danish: Hvad anvendes Ganfort til?
English: Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan.
Danish: Bimatoprost alene er allerede godkendt i Den Europæiske Union under navnet Lumigan.
English: Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways.
Danish: Ganfort indeholder to aktive stoffer, bimatoprost og timolol, som sænker trykket i øjet på forskellig vis. Bimatoprost er en prostaglandinanalog (en kopi af det naturlige stof prostaglandin), der virker ved at øge afstrømningen af væske fra øjet.
English: How does Ganfort work?
Danish: Hvordan virker Ganfort?
English: MA (EU) number (Invented) name
Danish: MF (EU)-number
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: The Member States should agree the local implementation of the patient card system.
Danish: Medlemslandene skal give samtykke til den lokale implementering af patientkortsystemet.
English: • The set-up of national measures to assess the effectiveness of and compliance with the PPP
Danish: • Implementeringen af nationale foranstaltninger for at vurdere effektiviteten og overholdelsen af PPP
English: The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
Danish: Medlemsstaterne skal sikre, at indehaveren af markedsføringstilladelsen implementerer et program til svangerskabsforebyggelse (PPP, Pregnancy Prevention Programme) inden for deres område.
English: • That Revlimid may cause neutropenia and thrombocytopenia and the need for regular blood tests
Danish: • At Revlimid kan forårsage neutropeni og trombocytopeni og at regelmæssige blodtest er nødvendige
English: The following information should also be provided in the appropriate brochure:
Danish: De efterfølgende informationer skal også findes i de tilsvarende brochurer:
English: • That the patient should not give Revlimid to any other person
Danish: • At patienten ikke må give Revlimid til andre personer
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the results of study CC-5013TOX-004
Danish: • Nødvendigheden af at undgå føtal eksponering pga. lenalidomids teratogenicitet hos dyr og den forventede teratogene effekt af lenalidomid hos mennesker, herunder en oversigt over resultaterne fra forsøg CC-5013-TOX-004
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans.
Danish: • At lenalidomid er teratogent hos dyr og forventes at have teratogen virkning hos mennesker
English: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the offlabel use within the national territory.
Danish: • Hvorledes indsamlingen af detaljerede data omkring indikationen kan gennemføres, så der opnås tæt overvågning af "off-label"-anvendelsen inden for eget område
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to Revlimid being dispensed
Danish: • Specifikke, nationale krav, som er aftalt med den kompetente, nationale myndighed angående: o Distribuering af produktet o Sikkerhed for at alle passende foranstaltninger er blevet iværksat, inden at Revlimid ordineres.
English: The Member States must 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, som er beskrevet nedenfor, med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet bliver implementeret:
English: The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare system and must implement such programme nationally to ensure that:
Danish: Medlemslandene skal sammen med indehaveren af markedsføringstilladelsen aftale detaljerne omkring et kontrolleret distributionssystem i overensstemmelse med de nationale bestemmelser og sundhedssystemer og implementere sådanne programmer nationalt for at sikre at:
English: Details of the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Danish: Detaljerne i dette program skal aftales med den kompetente, nationale myndighed i hvert enkelt medlemsland og være på plads, inden produktet lanceres på markedet.
English: • The need to stop Revlimid immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af omgående at ophøre med Revlimid, hvis der er mistanke om graviditet
English: The Member States should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the MAH and ensure that the materials contain the key elements as described below.
Danish: Medlemslandene skal aftale den finale ordlyd af den information, der stiles direkte til sundhedspersonale, og indholdet af informationspakken til læger med indehaveren af markedsføringstilladelsen og sikre, at materialet indeholder de nøgleelementer, der er beskrevet nedenfor.
English: • National or other applicable specific arrangements for a prescription for Revlimid to be dispensed
Danish: • Nationale eller andre specifikke foranstaltninger, der finder anvendelse, for at en recept på
English: • Pregnancy test regime o Before commencing treatment o During treatment every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
Danish: • Graviditetstest-regime o Før behandlingen påbegyndes o Hver 4. uge under behandlingen undtagen ved bekræftet æggeleder-sterilisation o Efter behandlingens afslutning
English: • Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
Danish: • Tjekliste til læger for at sikre at patienter modtager passende rådgivning angående behandlingen, præventionsmetoder og beskyttelse mod graviditet i overensstemmelse med køn og fødedygtighed
English: All patient brochures should contain the following elements:
Danish: Alle patientbrochurer bør indeholde følgende elementer:
English: • A core text as agreed by the CHMP.
Danish: • En kernetekst, som skal godkendes af Udvalget for Humanmedicinske Lægemidler (CHMP).
English: The Member States should also agree with the MAH prior to the launch of the product:
Danish: Medlemslandene skal ligeledes aftale følgende med indehaveren af markedsføringstilladelsen, før produktet lanceres på markedet:
English: • Safety advice relevant to all patients o Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials o Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience o Use in patients with hepatic and/or renal impairment o Disposal of unwanted medicine o Local country specific arrangements for a prescription for Revlimid to be dispensed o Description of risk of hypothyroidism o Explanation of unknown risk of neuropathy with long term use
Danish: • Råd om sikkerhed, som er relevante for alle patienter o Beskrivelse og håndtering af neutropeni og trombocytopeni, herunder incidensrater fra kliniske forsøg o Beskrivelse og håndtering af tromboemboli-risikoen, herunder incidensrater fra kliniske forsøg og erfaring efter markedsføring o Brug hos patienter med nedsat lever- og/eller nyrefunktion o Bortskaffelse af uønsket medicin o Lokale, national-specifikke foranstaltninger for at Revlimid, der ordineres på recept, kan udleveres o Beskrivelse af risikoen for hypothyroidisme o Forklaring angående den ikke kendte risiko for neuropati ved længerevarende brug.
English: • Brochure for women patients of childbearing potential and their partners
Danish: • En brochure til fødedygtige, kvindelige patienter og deres partnere
English: • Obligations of the health care professional in relation to the prescribing of Revlimid o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of Revlimid o Need to provide patients with appropriate patient educational brochure and patient card
Danish: • Sundhedspersonalets forpligtelser i forbindelse med ordineringen af Revlimid o Nødvendigheden af at forsyne patienterne med forståelig vejledning og rådgivning o Patienterne skal være i stand til at overholde de krav, der stilles til sikker brug af Revlimid o Nødvendigheden af at forsyne patienterne med informationsbrochure og patientkort
English: • Documentation of childbearing status potential
Danish: • Dokumentation om mulig fødedygtighed
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Danish: • Beskrivelse af PPP og kategorisering af patienter på basis af køn og fødedygtighed o Algoritme til implementering af PPP o Definition af fødedygtige kvinder og af de forholdsregler, som lægen skal tage i tvivlstilfælde
English: • Requirements in the event of pregnancy o Instructions to stop Revlimid immediately upon suspicion of pregnancy o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
Danish: • Krav i forbindelse med en opstået graviditet o Instruktion i omgående at ophøre med Revlimid, hvis der er mistanke om graviditet o Nødvendigheden af at opsøge en læge med speciale eller erfaring i teratologi til vurdering og rådgivning o Lokale kontaktdetaljer til rapportering af ethvert tilfælde om mistænkt graviditet o Formularer til rapportering af graviditet
English: • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception o Pregnancy test regime Advice on suitable tests Before commencing treatment During treatment based on method of contraception After finishing treatment o Need to stop Revlimid immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy
Danish: • Råd om sikkerhed, som er relevante for fødedygtige kvinder o Nødvendigheden af at undgå føtal eksponering o Beskrivelse af PPP o Nødvendigheden af effektiv prævention (også selvom kvinden har amenorrhoea) og definition af effektiv prævention o Graviditetstest-regime Rådgivning om passende test Før behandlingen påbegyndes Under behandlingen baserende på præventionsmetoden Efter behandlingens afslutning o Nødvendigheden af omgående at ophøre med Revlimid, hvis der er mistanke om graviditet o Nødvendigheden af omgående at oplyse det til lægen, hvis der er mistanke om graviditet
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af omgående at oplyse det til lægen, hvis der er mistanke om graviditet
English: • The need to use condoms if sexual partner is pregnant or a WCBP (even if man has had vasectomy) o During Revlimid treatment o For one week following final dose
Danish: • Nødvendigheden af at bruge kondomer, hvis partneren, som der er seksuelt samvær med, er gravid eller fødedygtig (også selvom manden er vasektomeret) o Under behandlingen med Revlimid o I én uge efter sidste dosis.
English: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below.
Danish: • Alle læger, som har til hensigt at ordinere Revlimid, og alle apoteker, der eventuelt udleverer Revlimid, modtager information, der stiles direkte til sundhedspersonale som beskrevet nedenfor, inden produktet lanceres på markedet.
English: • That if his partner becomes pregnant he should inform his treating doctor immediately
Danish: • At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid.
English: o That if his partner becomes pregnant whilst he is taking Revlimid or shortly after he has stopped taking Revlimid he should inform his treating doctor immediately
Danish: o At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid, imens han tager, eller kort tid efter, at han er ophørt med Revlimid
English: • Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP (even if man has had a vasectomy) During Revlimid treatment For one week following final dose.
Danish: • Råd om sikkerhed, som er relevante for mænd o Nødvendigheden af at undgå føtal eksponering o Nødvendigheden af at bruge kondomer, hvis partneren, som der er seksuelt samvær med, er gravid eller fødedygtig (også selvom manden er vasektomeret) Under behandlingen med Revlimid I en uge efter sidste dosis.
English: Direct Healthcare Professional Communication
Danish: Information, der stiles direkte til sundhedspersonale
English: Brochure for women patients with childbearing potential
Danish: Brochure til fødedygtige, kvindelige patienter
English: • Need for adequate contraception and definition of adequate contraception
Danish: • Nødvendigheden af effektiv prævention (også selvom kvinden har amenorrhoea) og definition af effektiv prævention
English: • Brochure for women patients who are not of childbearing potential
Danish: • En brochure til ikke-fødedygtige kvinder
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Danish: Informationspakken skal indeholde følgende: o Sæt med oplysningsmateriale til sundhedspersonale o Informationsbrochurer til patienter o Patientkort o Produktresume (SmPC), indlægsseddel og mærkning.
English: This may be because of manufacturing issues.
Danish: Det kan skyldes fremstillingsproblemer.
English: It is unlikely that you will be given too much.
Danish: Det er derfor usandsynligt, at du vil få for meget.
English: MARKETING AUTHORISATION NUMBER EU/1/16/1121/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER EU/1/16/1121/001
English: Symptoms of overdose are not known.
Danish: Symptomer på overdosering kendes ikke.
English: Some of these side effects may be serious and may lead to hospitalization.
Danish: Nogle af disse bivirkninger kan være alvorlige og medføre hospitalsindlæggelse.
English: There were no GvHD-related deaths or long-term complications.
Danish: Der var ingen GvHD-relaterede dødsfald eller langvarige komplikationer.
English: This medicinal product contains genetically-modified cells.
Danish: Dette lægemiddel indeholder genetisk modificerede celler.
English: This will ensure that the cells can be eliminated before they can cause damage to the patient's cells.
Danish: Dette vil sikre, at cellerne kan elimineres, før de kan beskadige patientens celler.
English: March 2021
Danish: Marts 2021
English: • You have not received the Certificate of Analysis.
Danish: • du ikke har modtaget analysecertifikatet.