FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Puregon is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Danish: Behandling med Puregon efterfølges sædvanligvis af administration af hCG for at inducere den sidste fase af follikelmodningen, genoptagelse af meiosen og follikelruptur.
English: * Women who are not ovulating A starting dose is set by your doctor.
Danish: • Kvinder som ikke har ægløsning Din læge fastsætter en startdosis.
English: To reduce the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment.
Danish: For at nedsætte risikoen for OHSS skal der udføres ultralydsscanning af follikeludviklingen før behandlingen og med regelmæssige intervaller under behandlingen.
English: Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before you proceed.
Danish: Rens ca. 5 cm rundt om indsprøjtningsstedet, og lad desinfektionsmidlet tørre i mindst 1 minut, før du går videre.
English: A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon.
Danish: Generelt anbefales det at bruge et "step-up"-behandlingsskema startende med en daglig administration på 50 IE Puregon.
English: Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Danish: Forhøjede endogene FSH-niveauer hos mænd indikerer primær testikellidelse.
English: After intramuscular administration of Puregon, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Danish: Efter intramuskulær administration af Puregon er de maksimale FSHkoncentrationer højere og opnås tidligere hos mænd end hos kvinder.
English: Puregon can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Danish: Puregon kan derfor bruges til stimulation af follikeludviklingen og produktionen af steroider i udvalgte tilfælde af manglende gonadal funktion.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; ATC code: G03G A06.
Danish: Farmakoterapeutisk klassifikation: Gonadotropin og andre ovulationsstimulerende midler, gonadotropiner; ATC-kode: G03G A06.
English: Do not mix Puregon with any other medicines.
Danish: Bland ikke Puregon sammen med anden medicin.
English: Puregon showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Danish: Puregon udviste intet mutagent potentiale i Ames' testen eller i in vitro-kromosomafvigelsestesten med humane lymfocytter.
English: Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
Danish: Puregon kan gives enten alene eller i kombination med en GnRH-agonist eller antagonist.
English: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
Danish: Hos ca. 4% af de kvinder, som blev behandlet med follitropin beta i kliniske studier, blev der rapporteret tegn på og symptomer med relation til ovarieoverstimulationssyndrom (OHSS) (se pkt.
English: • are allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
Danish: • du er allergisk over for follitropin beta eller et af de øvrige indholdsstoffer i Puregon (angivet i punkt 6)
English: Such patients are unresponsive to Puregon/hCG therapy.
Danish: Sådanne patienter reagerer ikke på Puregon/hCG behandling.
English: Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Puregeon.
Danish: Kvinder med kendte risikofaktorer for højt ovarierespons kan være særligt tilbøjelige til at udvikle OHSS under eller efter behandling med Puregon.
English: Generalised hypersensitivity reactions been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Danish: Generaliserede allergiske reaktioner er ikke almindelige (ca. 0,2% af alle patienter, der blev behandlet med follitropin beta).
English: Make a note of when you start storing the product out of the refrigerator.
Danish: Skriv ned, hvilken dag du begynder opbevaring af Puregon uden for køleskabet.
English: • Undiagnosed vaginal bleeding.
Danish: • Udiagnosticeret vaginalblødning.
English: This leaflet was last revised in Month YYYY
Danish: Denne indlægsseddel blev senest ændret måned ÅÅÅÅ
English: When using the pen-injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set.
Danish: Når injektionspennen anvendes skal man være opmærksom på, at pennen meget nøjagtigt afgiver den dosis, som den er indstillet til.
English: The first injection with Puregon should be performed under direct medical supervision.
Danish: Den første Puregon-injektion skal foretages under direkte lægelig supervision.
English: In the female the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.
Danish: Hos kvinder er koncentrationen af FSH kritisk for follikeludviklingens indtræden og varighed, og dermed for tidspunktet for og antallet af follikler, som modnes.
English: No data on acute toxicity of Puregon in humans is available, but the acute toxicity of Puregon and of urinary gonadotrophin preparations in animal studies has been shown to be very low.
Danish: Der er ingen tilgængelige data vedrørende akut toksicitet af Puregon hos mennesker, men dyreforsøg har vist en meget lav akut toksicitet af Puregon og gonadotropinpræparater udvundet af urin.
English: In these women the benefits of gonadotropin administration, including Puregon, need to be weighed against the risks.
Danish: Hos disse kvinder skal fordelene ved behandling med gonadotropin, herunder Puregon, opvejes mod risici.
English: Additionally for females
Danish: Yderligere for kvinder
English: In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with other gonadotrophins.
Danish: I sjældne tilfælde er tromboembolisme blevet forbundet med follitropin beta/hCG behandling, ligesom ved behandling med andre gonadotropiner.
English: Do not use Puregon
Danish: Tag ikke Puregon
English: Start again with Step 1 using a new syringe, new needles and a new vial of Puregon.
Danish: Start forfra med Trin 1, idet du bruger en ny nål og sprøjte og et nyt hætteglas med Puregon.
English: Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or under the skin (in the lower stomach, for example).
Danish: Indsprøjtningen indgives langsomt i en muskel (f.eks. i ballen, låret eller overarmen), eller lige under huden (f.eks. på maven).
English: Puregon has no or negligible influence on the ability to drive and use machines.
Danish: Puregon påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Puregon is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Danish: Puregon ordineres sædvanligvis i en dosis på 450 IE pr. uge, oftest i 3 doser a 150 IE i kombination med et andet hormon (hCG) i mindst 3 til 4 måneder.
English: If you forget to use Puregon
Danish: Hvis du har glemt at tage Puregon
English: • Malformations of the reproductive organs incompatible with pregnancy.
Danish: • Misdannelser af genitalier, som er uforenelig med graviditet.
English: Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Danish: Puregon anvendes i behandlingen af kvinder, som gennemgår ovarieinduktion eller kontrolleret ovarieoverstimulation i forbindelse med medicinsk assisteret reproduktionsbehandling.
English: Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Danish: Intravaskulær trombose, som kan opstå i vener eller arterier, kan give nedsat blodgennemstrømning til vitale organer eller ekstremiteter.
English: Rare side effects (may affect up to 1 in 1,000 people): - Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see warnings and precautions in section 2)
Danish: Sjældne bivirkninger (kan berøre op til 1 ud af 1.000 personer): - Blodpropper (kan også opstå, selvom æggestokkene ikke er utilsigtet overstimulerede, se Advarsler og forsigtighedsregler i punkt 2).
English: It is not known if treatment with fertility medicines increases the risk of these tumors in infertile women.
Danish: Det vides ikke, om behandlingen med fertilitetslægemidler øger risikoen for disse tumorer hos infertile kvinder.
English: Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'.
Danish: Brug ikke Puregon efter den udløbsdato, som er angivet på etiketten og yderkartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG.
Danish: Puregon bør gives i en dosis på 450 IE pr. uge, helst i 3 doser a 150 IE samtidig med hCG.
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in controlled ovarian stimulation).
Danish: Tabel 1: Resultater af studie 37.608 (randomiseret, gruppe-komparativt studie som sammenligner sikkerhed og effekt af Puregon med urinderiveret FSH ved kontrolleret ovariestimulation).
English: Concomitant use of Puregon and clomifene citrate may enhance the follicular response.
Danish: Samtidig brug af Puregon og clomifencitrat kan forstærke folliklernes respons.
English: In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.
Danish: Der er en øget risiko for OHSS ved ART (assisteret reproduktionsteknologi), hvis man observerer 18 eller flere follikler på 11 mm i diameter eller derover.
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in ovulation induction).
Danish: Tabel 2: Resultater af studie 37.609 (randomiseret, gruppe-komparativt studie, som sammenligner sikkerhed og effekt af Puregon med urin-deriveret FSH ved ovulations-induktion).
English: Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Danish: Puregon injektionsvæske, opløsning indeholder follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH).
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Danish: I kliniske studier, som sammenlignede brugen af recFSH (follitropin beta) og urinderiveret FSH til kontrolleret ovariestimulation hos kvinder, som får assisteret reproduktionsteknologisk (ART) behandling og til ovulations-induktion (se tabel 1 og 2 nedenfor), var Puregon mere potent end urinderiveret FSH.
English: If you inject yourself with Puregon, follow the instructions carefully to give Puregonproperly and with minimal discomfort.
Danish: Hvis du injicerer dig selv med Puregon så følg instruktionerne nøje, for at indgive Puregon korrekt og med mindst muligt ubehag.
English: If you inject yourself with Puregon, follow the instructions for use in the next section, to give Puregon properly and with minimal discomfort.
Danish: Hvis du injicerer dig selv med Puregon, så følg instruktionerne beskrevet i næste afsnit for at indgive Puregon korrekt og med mindst muligt ubehag.
English: If a GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Puregon may be needed.
Danish: Hvis du har fået en GnRH agonist (lægemiddel brugt til at forhindre tidlig ægløsning), kan det være nødvendigt at give dig en højere dosis Puregon.
English: Puregon is used to treat infertility in any of the following situations:
Danish: Puregon anvendes til behandling af barnløshed i følgende situationer:
English: If Puregon is used in a combination with clomifene citrate, the effect of Puregon may be increased.
Danish: Hvis Puregon anvendes samtidig med clomifencitrat, kan der opstå en øget effekt af Puregon.
English: If you are breast-feeding, tell your doctor before using Puregon.
Danish: Hvis du ammer, skal du fortælle det til din læge inden behandlingen med Puregon påbegyndes.
English: Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.
Danish: Puregon cylinderampuller er ikke fremstillet til at der opblandes andre stoffer i dem.
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Puregon, may further increase this risk.
Danish: Hos kvinder med almindeligt kendte risikofaktorer for trombose, såsom trombose i anamnesen, familiær disposition, svær overvægt eller trombofili, kan behandling med gonadotropiner, herunder Puregon, yderligere øge risikoen.
English: Furthermore Puregon can be used to promote multiple follicular development in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Danish: Endvidere kan Puregon bruges til at fremme udviklingen af multiple follikler ved medicinsk assisteret reproduktionsbehandling [f.eks. in vitro-fertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) og intracytoplasmisk sædcelleinjektion (ICSI)].
English: Other medicines and Puregon
Danish: Brug af anden medicin sammen med Puregon
English: Paediatric population There is no relevant use of Puregon in the paediatric population for the approved indication.
Danish: Pædiatrisk population Der er ingen relevante indikationer for Puregon i den pædiatriske population.
English: When using a GnRH agonist, a higher total treatment dose of Puregon may be required to achieve an adequate follicular response.
Danish: Ved anvendelse af en GnRH-agonist kan det være nødvendigt at give en højere total behandlingsdosis af Puregon for at opnå tilstrækkelig follikelrespons.
English: What you need to know before you use Puregon
Danish: Det skal du vide, før du begynder at tage Puregon
English: Using the pen, injections just under the skin (in the lower stomach, for example) can be given by yourself or your partner.
Danish: Du selv eller din partner kan med brug af pennen give injektionen lige under huden (f.eks. i den nedre del af maven).
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including Puregon.
Danish: Der er set flerfoldsgraviditeter og -fødsler ved alle gonadotropinbehandlinger, herunder med Puregon.
English: For ovulation induction, Puregon resulted in a lower median total dose and shorter median duration of treatment when compared to urinary FSH.
Danish: Ved ovulations-induktion resulterede behandling med Puregon i en lavere gennemsnitlig total-dosis og kortere gennemsnitlig behandlingsvarighed sammenlignet med urinderiveret FSH.
English: For controlled ovarian stimulation, Puregon resulted in a higher number of oocytes retrieved at a lower total dose and with a shorter treatment period, when compared to urinary FSH.
Danish: Ved kontrolleret ovariestimulation resulterede behandling med Puregon i, at et højere antal oocyter blev frembragt ved en lavere total-dosis og med en kortere behandlingsperiode, når der sammenlignedes med urinderiveret FSH.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Puregon.
Danish: Tromboemboliske hændelser, både med og uden forbindelse med OHSS, er rapporteret efter behandling med gonadotropiner, herunder Puregon.
English: Puregon is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det er ikke sandsynligt, at Puregon påvirker din evne til at køre motorkøretøj og betjene maskiner.
English: Too high a dose of Puregon may cause hyperstimulation of the ovaries (OHSS).
Danish: En for høj Puregon dosis kan forårsage overstimulation af æggestokkene (OHSS).
English: In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Danish: I mænd anvendes Puregon til behandling af utilstrækkelig spermatogenese forårsaget af hypogonadotropisk hypogonadisme.
English: A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in. Wash your hands and swab the injection site with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
Danish: Vask dine hænder og aftør indsprøjtningsstedet med et desinfektionsmiddel (f.eks. chlorhexidin 0,5%) for at fjerne bakterier.
English: Solution for injection 1 vial containing 0.5 mL 5 vials each containing 0.5 mL 10 vials each containing 0.5 mL
Danish: Injektionsvæske, opløsning 1 hætteglas indeholdende 0,5 ml 5 hætteglas hver indeholdende 0,5 ml 10 hætteglas hver indeholdende 0,5 ml
English: Puregon solution for injection contains:
Danish: Puregon injektionsvæske, opløsning indeholder:
English: • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
Danish: • Kontrolleret ovarieoverstimulation i forbindelse med medicinsk assisteret reproduktionsbehandling
English: After pituitary desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an adequate follicular response.
Danish: Efter desensibilisering af hypofysen ved brug af en GnRH-agonist, kan det være nødvendigt at give en højere dosis Puregon for at fremkalde tilstrækkelig follikelrespons.
English: It is unlikely that Puregon is passed into breast milk.
Danish: Det er ikke sandsynligt, at Puregon udskilles i mælken.
English: Depending on the ovarian response, the following measurements can be considered to reduce OHSS: - withhold further stimulation with a gonadotropin for a maximum of 3 days (coasting); - withhold hCG and cancel the treatment cycle;
Danish: Afhængigt af ovarierespons kan følgende foranstaltninger træffes for at nedsætte risikoen for OHSS: - undlade yderligere stimulering med gonadotropin i højst 3 dage (coasting); - seponere hCG og aflyse behandlingscyklus; - administrere en hCG-dosis lavere end 10.000 IE hCG for at udløse oocyt-modning, f.eks.
English: Store at or below 25°C for a single period of not more than 3 months.
Danish: Opbevares ved temperaturer på eller under 25°C i en enkelt periode, der ikke overstiger 3 måneder.
English: Puregon solution for injection comes in a glass vial.
Danish: Puregon injektionsvæsken findes i et hætteglas.
English: The administration of Puregon is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG).
Danish: Herefter afbrydes behandlingen med Puregon, og ovulation kan induceres ved at administrere humant choriongonadotropin (hCG).
English: For patient convenience, Puregon may be stored at or below 25ºC by the patient for a single period of not more than 3 months.
Danish: Hos patienten kan Puregon dog opbevares ved højst 25 °C i en enkelt periode, der ikke overstiger 3 måneder.
English: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Danish: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: - administer a dose lower than 10,000 IU of urinary hCG for triggering final oocyte maturation, e.g. 5,000 IU urinary hCG or 250 micrograms rec-hCG (which is equivalent to approximately 6,500 IU of urinary hCG); - cancel the fresh embryo transfer and cryopreserve embryos; - avoid administration of hCG for luteal phase support.
Danish: 5.000 IE hCG eller 250 mikrogram rec-hCG (som er ækvivalent med ca. 6.500 IE hCG); - aflyse oplægning af det friske embryon og cryopreservere embryonerne; - undgå administration af hCG til understøtning af lutealfasen.
English: • Each cartridge contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.
Danish: • Hver cylinderampul indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 833 IE i 1,0 ml vandig opløsning.
English: Ovarian and Other Reproductive System Tumours There have been reports of ovarian and other reproductive system tumors in women who have had infertility treatment.
Danish: Tumorer i æggestokkene og andre forplantningsorganer Der er rapporteret tumorer i æggestokke og andre forplantningsorganer hos kvinder, som har været i behandling for barnløshed.
English: Puregon solution for injection (injection) is a clear, colourless liquid.
Danish: Puregon-injektionsvæske, opløsning (injektionsvæske) er en klar og farveløs opløsning, som findes i et hætteglas.
English: * Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor.
Danish: • Medicinsk assisteret reproduktionsbehandling (kunstig befrugtning), f.eks. reagensglasbefrugtning (in vitro fertilisering (IVF)) Din læge fastsætter en startdosis.
English: Puregon treatment is then stopped and ovulation will be induced by giving human chorionic gonadotrophin (hCG).
Danish: Herefter afbrydes behandlingen med Puregon, og der fremkaldes ægløsning ved at give hormonet humant choriongonadotropin (hCG).
English: The very first injection of Puregon should only be given in the presence of a doctor or nurse.
Danish: Den første Puregon-indsprøjtning skal foretages under opsyn af en læge eller sygeplejerske.
English: What Puregon contains
Danish: Puregon indeholder:
English: • have uncontrolled pituitary gland or hypothalamic problems
Danish: • har sygdomme i hypofyse- eller hypotalamus, der ikke er under kontrol
English: The concurrent determination of serum oestradiol levels may also be useful.The patients should be advised of the potential risks of multiple births before starting treatment.
Danish: Patienterne bør informeres om den mulige risiko for flerfoldsfødsler før påbegyndelse af behandlingen.
English: Puregon solution for injection in cartridges has been developed for use in the Puregon Pen.
Danish: Puregon injektionsvæske, opløsning i cylinderampul er udviklet til anvendelse i Puregon Pen.
English: Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Danish: Derpå trykkes stemplet op, indtil al luft er presset ud, og der kun er Puregon tilbage i sprøjten (d).
English: Other medical conditions
Danish: Andre sygdomme
English: Ovarian torsion has occurred after treatment with gonadotropins including Puregon.
Danish: Ovarietorsion er opstået efter behandling med gonadotropiner, herunder Puregon.
English: 1025 IU recombinant FSH activity/1.230 mL Net content 900 IU
Danish: 1.025 IE rekombinant FSH aktivitet/1,230 ml Nettoindhold 900 IE
English: This strength corresponds to 83.3 microgram of protein / mL (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Denne styrke svarer til 83,3 mikrogram protein/ml (specifik in vivobioaktivitet svarende til ca. 10.000 IE FSH / mg protein).
English: Store at or below 25ºC (at room temperature) for a single period of not more than 3 months.
Danish: Opbevares ved temperaturer på eller under 25 °C i en enkelt periode, der ikke overstiger 3 måneder.