FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States.
Danish: Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Priligy 60 mg opvejer risiciene, og at der bør udstedes markedsføringstilladelse for Priligy (30 mg og 60 mg) i alle berørte medlemsstater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the 60 mg tablet (over which there was disagreement) do outweigh its risks and that the marketing authorisation for Priligy granted in Sweden can be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved 60 mg tabletten (som der var uenighed om) faktisk opvejer risiciene, og at den markedsføringstilladelse for Priligy, der er udstedt i Sverige, kan anerkendes i andre EUmedlemsstater.
English: The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine.
Danish: Begrundelsen for henvisningen var betænkeligheder ved benefit/risk-forholdet for 60 mg tabletten hos nogle medlemsstater, som anså dens ekstra fordel i forhold til 30 mg tabletter for at være for beskeden i forhold til den øgede risiko for svære tilfælde af synkope (besvimelse), der er set i undersøgelserne med lægemidlet.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012
Danish: Spørgsmål og svar om Priligy (dapoxetin, tabletter, 30 mg og 60 mg) EMA/106788/2012
English: The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.
Danish: Markedsføringstilladelsen blev fornyet den 3. maj 2001 og den 3. maj 2006.
English: It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Danish: Det produceres af en celle, der har fået indsat et gen (DNA), som sætter den i stand til at producere humant FSH.
English: The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment.
Danish: Dosis og indgivelseshyppighed af Puregon afhænger af brugen (se ovenfor) og patientens reaktion på behandlingen.
English: The most common side effects reported are a reaction and pain at the injection site.
Danish: De hyppigst indberettede bivirkninger er en reaktion eller smerter på injektionsstedet.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Puregon den 3. maj 1996.
English: Other information about Puregon:
Danish: Andre oplysninger om Puregon:
English: The marketing authorisation holder is N.V. Organon.
Danish: Indehaveren af markedsføringstilladelsen er N.V.
English: The full EPAR for Puregon is available here.
Danish: Den fuldstændige EPAR for Puregon findes her.
English: In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Danish: I kroppen regulerer FSH forplantningsfunktionen: Hos kvinder stimulerer det produktionen af æg, og hos mænd stimulerer det produktionen af sæd i testiklerne.
English: Puregon is given as a ‘subcutaneous' injection (under the skin) or into a muscle.
Danish: Puregon gives som en “subkutan” injektion (under huden) eller i en muskel.
English: Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems.
Danish: Behandling med Puregon skal foretages af en læge med erfaring i behandling af fertilitetsproblemer.
English: The Committee recommended that Puregon be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Puregon.
English: Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Danish: Puregon blev undersøgt hos 172 anovulatoriske kvinder, hvor man målte, hvor mange behandlingscyklusser der skulle til, for at disse kvinder fik ægløsning.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PUREGON EPAR - sammendrag for offentligheden
English: Puregon's use in women undergoing fertility treatment has been studied in 981 patients.
Danish: Anvendelsen af Puregon til kvinder i fertilitetsbehandling er blevet undersøgt hos 981 patienter.
English: Puregon is used to treat infertility in women in the following situations:
Danish: Puregon anvendes til behandling af kvindelig infertilitet i følgende situationer:
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
Danish: • Kvinder, der er anovulatoriske (ikke producerer æg) og ikke reagerer på behandling med clomifencitrat (et andet lægemiddel, der stimulerer ægløsning).
English: The powder should be mixed with the solvent provided just before use.
Danish: Pulveret skal blandes med den medfølgende solvens umiddelbart før brug.
English: Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Danish: Puregon indgives for at stimulere æggestokkene til at producere mere end ét æg ad gangen.
English: Puregon contains the active substance follitropin beta.
Danish: Puregon indeholder det aktive stof follitropin beta.
English: The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'.
Danish: Follitropin beta i Puregon produceres ved hjælp af en metode kaldet "rekombinant DNA-teknologi".
English: Puregon should only be administered by people who have been trained by the doctor and have access to expert advice.
Danish: Puregon bør kun gives af personer, som er blevet instrueret af en læge og har adgang til ekspertrådgivning.
English: In 4 % of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, and diarrhoea) have been reported.
Danish: Hos 4 % af de kvinder, der fik behandling med Puregon i kliniske undersøgelser, er der indberettet tegn og symptomer på ovarielt hyperstimulationssyndrom (f.eks. kvalme, vægtøgning og diarré).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Puregon er større end risiciene for kvinder ved behandling af infertilitet og for mænd ved utilstrækkelig spermatogenese forårsaget af hypogonadotropisk hypogonadisme.
English: In men, Puregon was studied to see its effect on sperm production in 49 patients.
Danish: Hos mænd blev Puregon undersøgt for at måle effekten på sædproduktionen hos 49 patienter.
English: Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Danish: Puregon kan også anvendes til at stimulere sædproduktionen hos mænd med hypogonadotrop hypogonadisme (en sjælden hormondefektsygdom).
English: Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Danish: Puregon må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for follitropin beta eller et eller flere af de øvrige indholdsstoffer.
English: Puregon can only be obtained with a prescription.
Danish: Puregon udleveres kun efter recept.
English: In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine.
Danish: I alle undersøgelserne blev Puregon sammenlignet med det naturlige FSH-hormon, der blev udvundet af urin.
English: What is the risk associated with Puregon?
Danish: Hvilken risiko er der forbundet med Puregon?
English: Puregon is a powder and solvent to be made up into a solution for injection.
Danish: Puregon er pulver og solvens, der blandes til en opløsning til injektion.
English: The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Danish: Det aktive stof i Puregon, follitropin beta, er en kopi af det naturlige hormon FSH (follikelstimulerende hormon).
English: Puregon was as effective as the comparator in all of the studies.
Danish: I alle undersøgelserne var Puregon lige så effektivt som sammenligningsstoffet.
English: Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Danish: Puregon må ikke anvendes til patienter med svulster i æggestokkene, brystet, livmoderen, testiklerne, hypofysen eller hypothalamus.
English: For a full list of all side effects reported with Puregon, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Puregon fremgår af indlægssedlen.
English: In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
Danish: Det må ikke anvendes til kvinder med ovarieinsufficiens, forstørrede æggestokke eller cyster på æggestokkene, der ikke skyldes polycystisk ovariesyndrom eller vaginal blødning.
English: Why has Puregon been approved?
Danish: Hvorfor blev Puregon godkendt?
English: Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Danish: Som fertilitetsbehandling var Puregon lige så effektivt som FSH fra urin og lige så effektivt til at fremkalde ægløsning og stimulere sædproduktion.
English: What is Puregon?
Danish: Hvad er Puregon?
English: For a full description of the doses, please see the Package Leaflet.
Danish: En fuldstændig beskrivelse af doseringen fremgår af indlægssedlen.
English: What benefit has Puregon shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Puregon?
English: What is Puregon used for?
Danish: Hvad anvendes Puregon til?
English: It is also available as a solution for injection in a vial or a cartridge.
Danish: Det findes også som en opløsning til injektion i et hætteglas eller en ampul.
English: How has Puregon been studied?
Danish: Hvordan blev Puregon undersøgt?
English: How is Puregon used?
Danish: Hvordan anvendes Puregon?
English: How does Puregon work?
Danish: Hvordan virker Puregon?
English: Oral use blister (OPA/aluminium/PVC/ aluminium)
Danish: (OPA/aluminium/PVC/aluminium)
English: 84 tablets
Danish: tabletter
English: 40 mg
Danish: 40 mg Filmovertrukne tabletter
English: Film-coated tablet
Danish: Oral anvendelse Blister
English: Cats and dogs
Danish: Katte og hunde Subkutan anvendelse
English: Your doctor will discuss this with you.
Danish: Deres læge vil drøfte dette med Dem.
English: Adult and children (1 to 17 years):
Danish: Voksne og børn (1 til 17 år):
English: The European Medicines Agency has waived the obligation to submit data for children < 1 year.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge data for børn < 1 år.
English: Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
Danish: Dato for første markedsføringstilladelse: 4. februar 2009 Dato for seneste fornyelse: 20. december 2013
English: The injection volume may be very small.
Danish: Injektionsvoluminet kan være meget lille.
English: Your doctor will tell you how much you must take.
Danish: Deres læge vil fortælle Dem, hvor meget De skal tage.
English: Reassessment of body weight is recommended every 12 weeks.
Danish: Revurdering af legemsvægt anbefales hver 12. uge.
English: • Wash your hands with soap and warm water.
Danish: • Vask Deres hænder med sæbe og varmt vand.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Danish: Som for alle terapeutiske proteiner er der mulighed for immunogenicitet.
English: Combined studies 1 & 2
Danish: Kombineret undersøgelse 1 og 2
English: The overall safety profile was similar to that seen in adults.
Danish: Den samlede sikkerhedsprofil var den samme, som den der sås hos voksne.
English: Read all instructions for use thoroughly.
Danish: Læs alle instruktioner til anvendelsen grundigt.
English: Generally, dissolution of Nplate takes less than 2 minutes.
Danish: Opløsning af Nplate tager som regel under 2 minutter.
English: Before you begin
Danish: Inden De går i gang
English: Perform step 3a before step 3b.
Danish: Udfør trin 3a før trin 3b.
English: • Do check your dose before starting this step.
Danish: • Kontrollér Deres dosis, inden De går i gang med dette trin.
English: Initial or subsequent once weekly dose:
Danish: Begyndelses- eller efterfølgende ugentlig dosis:
English: It may harm them,
Danish: • ondt i halsen og ubehag ved synkning (faryngit),
English: Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products.
Danish: Det er muligt, at patienterne ikke har en ugentlig respons inden for 8 uger efter indgift af eventuelle ”rescue”-lægemidler.
English: Progression of existing Myelodysplastic Syndromes (MDS)
Danish: Progression af eksisterende myelodysplastiske syndromer (MDS)
English: • The product is now ready for injection.
Danish: • Produktet er herefter klar til at blive injiceret.
English: Component of a multipack, not to be sold separately.
Danish: Enhed i en multipakke; der ikke må sælges separat.
English: This is a protein product and proteins can be easily damaged by improper mixing and excessive shaking.
Danish: Dette er et proteinprodukt, og proteiner ødelægges nemt ved forkert blanding og for kraftig omrysten.
English: You do not have to maintain pressure on the plunger for the rest of Step 4.
Danish: De behøver ikke opretholde trykket på stemplet i resten af trin 4.
English: • If you are at risk of blood clots or if blood clots are common in your family.
Danish: • Hvis De har risiko for blodpropper, eller hvis blodpropper er almindelige i Deres familie.
English: The median duration of exposure was 65.4 weeks.
Danish: Den gennemsnitlige eksponeringsvarighed var 65,4 uger.
English: Both studies were similarly designed.
Danish: Designet var det samme for begge undersøgelser.
English: • There may be a little bleeding at the injection site.
Danish: • Der kan være lidt blødning på injektionsstedet.
English: • allergic reaction;
Danish: • allergisk reaktion,
English: Worsening of blood cancers
Danish: Forværring af blodkræft
English: Nplate should be reconstituted in accordance with good aseptic practice.
Danish: Nplate skal rekonstitueres i overensstemmelse med god aseptisk praksis.
English: • if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for romiplostim eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: In the post-marketing registry study, 19 confirmed paediatric patients were included.
Danish: I registerundersøgelsen efter markedsføring blev der inkluderet 19 bekræftede pædiatriske patienter.
English: Adjust the dose as follows:
Danish: Dosis justeres som følger:
English: After the first 4 weeks of self-administration, the patient should again be supervised while reconstituting and administering Nplate.
Danish: Efter de første 4 ugers selvadministration skal patienten igen overvåges, mens Nplate fortyndes og administreres.
English: Overall survival was similar to placebo.
Danish: Den samlede overlevelse svarede til placebo.
English: Do not use Nplate:
Danish: Brug ikke Nplate:
English: • Note: The Nplate liquid is highly potent which is why accuracy and dose measurement are important.
Danish: • Bemærk: Nplate-væsken er meget kraftig, hvorfor nøjagtighed og afmåling ved dosis er vigtigt.
English: Effects of romiplostim on red and white blood cells
Danish: Virkningerne af romiplostim på røde og hvide blodlegemer
English: The solvent is a clear colourless liquid.
Danish: Solvensen er en klar, farveløs væske.
English: • Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit.
Danish: • Bemærk: Hvis Deres sundhedsmedarbejder har fortalt Dem, at Deres dosis af Nplate kræver mere end én injektion af Nplate, skal De bruge mere end ét selvinjektionssæt.
English: Do not use if frozen.
Danish: Brug ikke hvis det er frossent.
English: Monitoring of these parameters should be considered in patients treated with romiplostim.
Danish: Monitorering af disse parametre skal overvejes hos patienter, der behandles med romiplostim.
English: No formal clinical trials have been conducted in these patient populations.
Danish: Der er ikke udført formelle kliniske forsøg for disse patientgrupper.
English: You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely.
Danish: De skal tale med Deres læge, inden De kører bil eller betjener maskiner, da nogle bivirkninger (f.eks. forbigående anfald af svimmelhed) kan forringe Deres evne til at gøre dette på en sikker måde.
English: • Do not re-use items.
Danish: • Genbrug ikke artiklerne.
English: In these studies, myelofibrosis was not observed in animals after a 4-week post-treatment recovery period, indicating reversibility.
Danish: I disse undersøgelser blev der ikke set myelofibrose hos dyr efter en restitutionstid på 4 uger efter behandling, hvilket indikerer reversibilitet.
English: > 150 for two consecutive weeks
Danish: > 150 i to uger i træk
English: • protein in the urine.
Danish: • protein i urinen.
English: Do the following:
Danish: Gør følgende:
English: There are no or limited amount of data from the use of romiplostim in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af romiplostim til gravide kvinder.
English: Children (1 to 17 years old): in addition to adjusting your dose based on platelet counts, your doctor will also regularly reassess your body weight in order to adjust your dose.
Danish: Børn (1 til 17 år): udover justering af Deres dosis baseret på blodpladetallet, vil Deres læge også regelmæssigt veje Dem for at kunne justere Deres dosis.
English: This should help to prevent bruising and bleeding associated with ITP.
Danish: Dette skal hjælpe med at forhindre blå mærker og blødning forbundet med ITP.
English: However, the data are insufficient to draw any meaningful conclusion relating to the impact of dose and age on the pharmacokinetics of romiplostim.
Danish: Dataene er dog utilstrækkelige til at drage en meningsfuld konklusion vedrørende virkningen af dosis og alder på romiplostims farmakokinetik.
English: Nplate will be given under the direct supervision of your doctor, who will closely control the amount of Nplate given to you.
Danish: Nplate vil blive givet under direkte opsyn af Deres læge, som omhyggeligt vil kontrollere den mængde Nplate, som De får.
English: There is no data available on fertility.
Danish: Der foreligger ikke data vedrørende virkning på fertilitet.
English: The safety and efficacy of romiplostim have been evaluated for up to 3 years of continuous treatment.
Danish: Sikkerheden og effekten ved romiplostim er blevet undersøgt under op til 3 års kontinuerlig behandling.
English: If someone else is giving you the injection, they can also use the outer area of the upper arms
Danish: Hvis en anden giver Dem injektionen, kan ydersiden af overarmene også bruges
English: Air bubbles: Incorrect
Danish: Luftbobler: forkert
English: Three recommended injection sites for Nplate include: Front of the middle thighs
Danish: De tre anbefalede injektionssteder for Nplate er: Midt på lårene foran
English: Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Danish: Selvom det på grundlag af disse data ikke er nødvendigt at justere doseringsregimet med henblik på behandling af ældre patienter, tilrådes det dog at være forsigtig i betragtning af det lille antal ældre patienter, der har været inkluderet i kliniske undersøgelser indtil nu.
English: Do not try to inject yourself if you have not been trained.
Danish: Forsøg ikke at injicere Dem selv, hvis De ikke har fået undervisning i det.
English: 9/L after dose reduction or treatment discontinuation.
Danish: 9/l efter dosisreduktion eller seponering af behandlingen.
English: • Make sure you have the following items: Alcohol swab package x4
Danish: • Sørg for at have følgende artikler klar: Pakning med sprittamponer x4
English: If necessary push liquid back into the vial to achieve the desired dose.
Danish: Skub om nødvendigt væske tilbage i hætteglasset for at opnå den ønskede dosis.
English: Only patients who demonstrate the ability to reconstitute and self-administer Nplate are allowed to continue doing so.
Danish: Kun patienter, der udviser evne til at fortynde og selv administrere Nplate, må fortsætte med at gøre det.
English: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Doses were adjusted to maintain (50 to 200 x 10
Danish: Doserne blev justeret for at fastholde (50 til 200 x 10
English: After the first month of self-injecting Nplate, you will need to show that you can still prepare and inject Nplate correctly.
Danish: Efter den første måned med selvinjektion af Nplate vil De skulle vise, at De stadig kan tilberede og injicere Nplate korrekt.
English: See table 2 below for dose adjustment and monitoring.
Danish: Se nedenstående tabel 2 for dosisjustering og monitorering .
English: The carcinogenic potential of romiplostim has not been evaluated.
Danish: Romiplostims karcinogene potentiale er ikke blevet evalueret.
English: Before continuing:
Danish: Inden der fortsættes:
English: • Do not touch this area again before giving the injection.
Danish: • Rør ikke dette sted igen, før injektionen skal gives.
English: Multipack: comprising 4 packs Each pack contains:
Danish: Multipakke: indeholder 4 pakninger Hver pakning indeholder:
English: No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
Danish: Der er ikke observeret nogen generel forskel på sikkerhed eller virkning for patienter < 65 og ≥ 65 år (se pkt.
English: Push slowly and gently
Danish: Tryk langsomt og forsigtigt
English: These changes may lead to abnormal blood cells or your body making less blood cells.
Danish: Disse forandringer kan medføre unormale blodceller, eller at kroppen danner færre blodceller.
English: • Do dissolve slowly and carefully.
Danish: • Husk at opløse langsomt og forsigtigt.
English: Subject incidence was 1 (0.4%) for either grade ≥ 3 or serious thrombocytosis.
Danish: Incidensraten var 1 (0,4 %) for alle grader ≥ 3 eller alvorlig trombocytose.
English: In mice there was evidence of increased post-implantation loss.
Danish: Hos mus var der tegn på øget tab efter implantation.
English: Reduction in permitted concurrent ITP medical therapies
Danish: Reduktion i tilladte samtidige medicinske behandlinger af ITP