FrancophonIA/ELRC3.0 huggingface dataset:
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Danish: Overstimulation af æggestokkene kan føre til en lidelse kaldet ovarielt hyperstimulationssyndrom (OHSS), som kan være et alvorligt problem.
English: It is unlikely that Fertavid is passed into breast milk.
Danish: Det er ikke sandsynligt, at Fertavid udskilles i mælken.
English: If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levels indicate an adequate pharmacodynamic response.
Danish: Hvis der ingen ovarierespons er, forhøjes den daglige dosis gradvist, indtil follikelvæksten og/eller estradiolniveauerne indikerer et tilstrækkeligt farmakodynamisk respons.
English: When using a GnRH agonist, a higher total treatment dose of Fertavid 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 Fertavid for at opnå tilstrækkelig follikelrespons.
English: Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain.
Danish: Kliniske tegn og symptomer på svær OHSS er store ovariecyster, akutte abdominalsmerter, ascites, pleuraeffusion, hydrothorax, dyspnø, oliguri, hæmatologiske abnormiteter og vægtøgning.
English: Fertavid should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG.
Danish: Fertavid bør gives i en dosis på 450 IE pr. uge, helst i 3 doser a 150 IE samtidig med hCG.
English: If Fertavid is used in a combination with clomifene citrate, the effect of Fertavid may be increased.
Danish: Hvis Fertavid anvendes samtidig med clomifencitrat, kan der opstå en øget effekt af Fertavid.
English: If you inject yourself with Fertavid, follow the instructions for use in the next section, to give Fertavid properly and with minimal discomfort.
Danish: Hvis du injicerer dig selv med Fertavid, så følg instruktionerne beskrevet i næste afsnit for at indgive Fertavid korrekt og med mindst muligt ubehag.
English: OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form.
Danish: OHSS medfører, at der pludselig ophobes væske i mave og brystkasse, og OHSS kan medføre, at der dannes blodpropper.
English: Mean no. of oocytes retrieved Mean total dose (no. of 75 IU ampoules) Mean duration of FSH stimulation (days)
Danish: Gennemsnitligt antal oocyter frembragt Gennemsnitlig total-dosis (antal 75 IE ampuller) Gennemsnitlig varighed af FSH stimulation (dage)
English: Other medicines and Fertavid
Danish: Brug af anden medicin sammen med Fertavid
English: Furthermore Fertavid 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 Fertavid 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: 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), follitropin beta 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 follitropin beta mere potent end urinderiveret FSH.
English: When given into a muscle the injection should be given by the doctor or nurse.
Danish: Indsprøjtning i en muskel (intramuskulært) må kun indgives af en læge eller sygeplejerske.
English: Dosage in women
Danish: Dosering til kvinder
English: It is not established whether or not treatment with gonadotrophins increases the risk of these tumours in infertile women.
Danish: Det er ikke fastslået, om behandling med gonadotropiner forøger risikoen for disse tumorer hos infertile kvinder.
English: The subcutaneous injection site should be alternated to prevent lipoatrophy.
Danish: Ved subkutan injektion bør injektionsstedet varieres for at forhindre lipoatrofi.
English: If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/or plasma oestradiol levels indicate a proper response.
Danish: Hvis æggestokkene ikke reagerer, øges den daglige dosis gradvist, indtil follikelvæksten og/eller plasmakoncentrationen af estradiol viser en passende reaktion.
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta 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 follitropin beta med urinderiveret FSH ved kontrolleret ovariestimulation).
English: • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
Danish: • Tumorer i ovarierne, mammae, uterus, testis, hypofysen eller hypothalamus.
English: • have ovaries that do not work because of a condition called primary ovarian failure
Danish: • dine æggestokke ikke fungerer pga. en sygdom, som kaldes primær ovarieinsufficiens
English: • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Danish: • Kontrolleret ovarieoverstimulation med henblik på at inducere udvikling af multiple follikler i forbindelse med medicinsk assisteret reproduktionsbehandling [f.eks. in vitrofertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) og intracytoplasmisk sædcelleinjektion (ICSI)].
English: Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
Danish: Træk nålen hurtigt ud og pres et stykke vat med desinfektionsmiddel ned på indsprøjtningsstedet.
English: Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Danish: Fertavid injektionsvæske, opløsning indeholder follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH).
English: • blood vessel problems (thrombophlebitis)
Danish: • problemer i blodkar (tromboflebitis)
English: Call your doctor right away if you notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), vomiting, sudden weight gain due to fluid buildup, diarrhoea, decreased urine output or trouble breathing (see also section 4 on Possible side effects).
Danish: Kontakt straks lægen, hvis du oplever stærkt oppustet mave, mavesmerter, kvalme, opkastning, pludselig vægtstigning som følge af væskeophobning, diarré, nedsat vandladning eller vejrtrækningsproblemer (se også punkt 4 ”Bivirkninger”).
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta with urinary FSH in ovulation induction).
Danish: Tabel 2: Resultater af studie 37.609 (randomiseret, gruppe-komparativt studie, som sammenligner sikkerhed og effekt af follitropin beta med urin-deriveret FSH ved ovulations-induktion).
English: The starting dose is maintained for at least seven days.
Danish: Dosis vedligeholdes i mindst 7 dage.
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including follitropin beta.
Danish: Der er set flerfoldsgraviditeter og -fødsler ved alle gonadotropinbehandlinger, herunder med follitropin beta.
English: If a GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Fertavid 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 Fertavid.
English: Step 7 - Removing the syringe
Danish: Trin 7 - Fjernelse af nålen
English: Do not use Fertavid
Danish: Tag ikke Fertavid
English: This serious medical condition is called ovarian hyperstimulation syndrome (OHSS).
Danish: Denne alvorlige lidelse kaldes ovarieoverstimulationssyndrom (OHSS).
English: Ovarian torsion has occurred after treatment with gonadotropins including Fertavid.
Danish: Ovarietorsion er opstået efter behandling med gonadotropiner, herunder Fertavid.
English: Pinch the skin a little.
Danish: Tag fat i en hudfold med den ene hånd.
English: Before starting to use this medicine, tell your doctor if you:
Danish: Før du starter med at bruge denne medicin, skal du fortælle lægen, hvis du:
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 eller din partner kan med brug af pennen give indsprøjtningen lige under huden (f.eks. i den nedre del af maven).
English: It is available in packs of 1 cartridge.
Danish: Den fås i en pakke med 1 cylinderampul.
English: Fertavid cartridges are not designed to allow any other drug to be mixed in the cartridges.
Danish: Fertavid cylinderampuller er ikke fremstillet til at der opblandes andre stoffer i dem.
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 Deres hænder og aftør indsprøjtningsstedet med et desinfektionsmiddel (f.eks. chlorhexidin 0,5%) for at fjerne bakterier.
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: In case of inadvertent exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Danish: Kliniske data er ikke tilstrækkelige til at udelukke en teratogen effekt af rekombinant FSH i tilfælde af utilsigtet eksponering under graviditet.
English: The dosage should, therefore, be adjusted individually depending on the ovarian response.
Danish: Derefter justeres dosis individuelt afhængigt af ovariernes respons.
English: When ultrasound assessment indicates the presence of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG. Oocyte retrieval is performed 34-35 hours later.
Danish: Når ultralydsscanningen viser tilstedeværelse af mindst 3 follikler, som måler 16-20 mm, og der er opnået en god estradiolrespons (plasmaniveauer på ca. 300-400 picogram/ml (1.000-1.300 pmol/l) for hver follikel med en diameter større end 18 mm), induceres den sidste fase af follikelmodningen ved indgivelse af hCG. Ægudtagningen finder sted 34-35 timer senere.
English: • have ever had ovarian hyperstimulation syndrome OHSS
Danish: • nogensinde har haft ovarielt hyperstimulationssyndrom (OHSS)
English: • are a man and are infertile because of a condition called primary testicular failure.
Danish: • du er en mand og er ufrugtbar på grund af en testikelsygdom.
English: In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported.
Danish: Derudover er der rapporteret om ektopisk graviditet, spontan abort og flerfoldsgraviditeter.
English: Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts.
Danish: De kliniske tegn og symptomer på let eller moderat OHSS er abdominalsmerter, kvalme, diarre, let til moderat forstørrelse af ovarierne samt ovariecyster.
English: • have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
Danish: • du har cyster på æggestokkene eller forstørrede æggestokke, som ikke skyldes sygdommen polycystisk ovariesyndrom (PCOS)
English: Any remaining solution should be discarded.
Danish: Overskydende opløsning skal destrueres.
English: Fertavid is used to treat infertility in any of the following situations:
Danish: Fertavid anvendes til behandling af barnløshed i følgende situationer:
English: This is thought to be due to differences in parental characteristics (e.g., maternal age, sperm characteristics) and multiple gestations.
Danish: Dette skyldes formodentlig faktorer hos forældrene (f.eks. moderens alder, faderens sædkvalitet) og flerfoldsgraviditeter.
English: This makes it impossible to set a uniform dosage scheme.
Danish: Dette gør det umuligt at opsætte et doseringsskema, som passer på alle patienter.
English: Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
Danish: Når nålen er stukket igennem gummimembranen på cylinderampullen må produktet opbevares i maksimum 28 dage.
English: What you need to know before you use Fertavid
Danish: Det skal du vide, før du begynder at tage Fertavid
English: Ovarian and Other Reproductive System Neoplasms There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Danish: Neoplasmer på ovarier og i de øvrige reproduktive organer Der er rapporteret om både benigne og maligne neoplasmer i ovarier og andre forplantningsorganer hos kvinder, som har gennemgået behandlinger med adskillige behandlingsregimer i forbindelse med fertilitetsbehandling.
English: • have fibroid tumours in the uterus which make a normal pregnancy impossible
Danish: • du har muskelknuder (fibromer) i livmoderen, som gør det umuligt at gennemføre en normal graviditet
English: Twisting of the ovary could cause the blood flow to the ovary to be cut off.
Danish: Vridning af æggestokken kan medføre, at blodgennemstrømningen til æggestokken afskæres.
English: • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
Danish: • Kontrolleret ovarieoverstimulation i forbindelse med medicinsk assisteret reproduktionsbehandling.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, skal du tale med din læge, sygeplejerske eller apoteket.
English: Fertavid solution for injection comes in a glass vial.
Danish: Fertavid-injektionsvæsken findes i et hætteglas.
English: If you are breast-feeding, tell your doctor before using Fertavid.
Danish: Hvis du ammer, skal du fortælle det til din læge inden behandlingen med Fertavid påbegyndes.
English: Pack of 1, 5 or 10 vials.
Danish: Pakninger med 1, 5 eller 10 hætteglas.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including follitropin beta.
Danish: Tromboemboliske hændelser, både med og uden forbindelse med OHSS, er rapporteret efter behandling med gonadotropiner, herunder follitropin beta.
English: For ovulation induction, follitropin beta 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 follitropin beta i en lavere gennemsnitlig totaldosis og kortere gennemsnitlig behandlingsvarighed sammenlignet med urinderiveret FSH.
English: Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery.
Danish: Hvis der suges blod tilbage i sprøjten, betyder det, at nålens spids har gennemtrængt en blodåre.
English: This is produced by recombinant DNA technology, using a Chinese hamster ovary cell line transfected with the human FSH subunit genes.
Danish: Dette stof produceres ved hjælp af rekombinant DNAteknologi, idet der anvendes ovarieceller fra kinesiske hamstere, som er tilført de humane gener for FSH-subunit.
English: For controlled ovarian stimulation, follitropin beta 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 follitropin beta 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: It is available in packs of 1, 5 or 10 vials.
Danish: Den fås i pakninger med 1, 5 eller 10 hætteglas.
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Danish: Injektionsvæsken indeholder det aktive stof follitropin beta, som er fremstillet ved genetisk manipulation af ovarieceller fra kinesiske hamstere (CHO).
English: In males Fertavid is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Danish: Hos mænd anvendes Fertavid til behandling af utilstrækkelig spermatogenese forårsaget af hypogonadotropisk hypogonadisme.
English: Breast complaints Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage
Danish: Ovariecyster Forstørrelse af ovarierne Ovarietorsion Forstørrelse af uterus Vaginalblødning
English: Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Danish: Den dato cylinderampullen tages i brug skrives på doseringskortet som vist i instruktionen for Puregon Pen.
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
English: • blockage in your lungs (pulmonary embolus)
Danish: • tilstopning af lungerne (blodprop i lungen)
English: Abdominal discomfort Constipation Diarrhoea
Danish: Abdominale gener Forstoppelse Diarré
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.
Danish: polycystisk ovariesyndrom) hos kvinder, som ikke har responderet på behandling med clomifencitrat.
English: Generalised hypersensitivity reaction
Danish: Generaliseret allergisk reaktion
English: Intramuscular (IM) and subcutaneous (SC) use The contents of the vial should be used immediately after piercing of the rubber stopper.
Danish: og subkutan (s.c.) anvendelse Indholdet i et hætteglas bør bruges straks efter, at gummihætten er perforeret.
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/mL aqueous solution.
Danish: Injektionsvæsken indeholder det aktive stof follitropin beta, som er fremstillet ved genetisk manipulation af ovarieceller fra kinesiske hamstere (CHO), i en koncentration på 833 IE/ml vandig opløsning.
English: • have uncontrolled pituitary gland or hypothalamic problems
Danish: • har sygdomme i hypofyse eller hypotalamus, der ikke er under kontrol
English: You may regularly have ultrasound scans of the ovaries.
Danish: Overvågningen sker ved regelmæssige ultralydsscanninger af æggestokkene.
English: Too high a dose of Fertavid may cause hyperstimulation of the ovaries (OHSS).
Danish: En for høj Fertavid dosis kan forårsage overstimulation af æggestokkene (OHSS).
English: Local reactions at the site of injection include: bruising, pain, redness, swelling and itching 3.
Danish: Lokale reaktioner på injektionsstedet inkluderer: blå mærker, smerter, rødme, hævelse og kløe 3.
English: Adverse reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.
Danish: Bivirkninger med relation til dette syndrom inkluderer bækkensmerter og/eller forstoppelse, smerter i abdomen og/eller distension, brystgener og forstørrelse af ovarierne.
English: • have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
Danish: • du har svulster i æggestokkene, brysterne, livmoderen, testiklerne eller hjernen (hypofysen eller hypotalamus)
English: Fertavid solution for injection (injection) is a clear, colourless liquid.
Danish: Fertavid-injektionsvæske, opløsning (injektionsvæske) er en klar og farveløs opløsning, som findes i et hætteglas.
English: • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
Danish: • Ovariecyster eller forstørrede ovarier som ikke har relation til polycystisk ovariesyndrom
English: After pituitary desensitisation induced by a GnRH agonist, a higher dose of Fertavid 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 Fertavid for at fremkalde tilstrækkelig follikelrespons.
English: Keep the cartridge in the outer carton.
Danish: Opbevar hætteglasset i den ydre karton.
English: Uncommon side effects (may affect up to 1 in 100 people): - Breast complaints (including tenderness) - Diarrhoea, constipation or stomach discomfort - Enlargement of the uterus - Feeling sick - Hypersensitivity reactions (such as rash, redness, hives and itching) - Ovarian cysts or enlargement of the ovaries - Ovarian torsion (twisting of the ovaries) - Vaginal bleeding
Danish: Ikke almindelige bivirkninger (kan berøre op til 1 ud af 100 personer): - Brystgener (inklusive ømhed) - Diarré, forstoppelse eller mavegener - Forstørrelse af livmoderen - Kvalme - Overfølsomhedsreaktioner (såsom udslæt, rødmen, nældefeber og kløe) - Cyster i æggestokkene eller forstørrelse af æggestokkene - Ovarietorsion (drejning af æggestokkene) - Blødning fra skeden.
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: The contents of a vial should be used immediately after piercing the rubber stopper.
Danish: Indholdet i et hætteglas bør bruges straks efter, at gummilukket er perforeret.
English: For patient convenience, Fertavid may be stored at or below 25ºC by the patient for a single period of not more than 3 months.
Danish: Hos patienten kan Fertavid dog opbevares ved højst 25 °C i en enkelt periode, der ikke overstiger 3 måneder.
English: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Danish: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
English: Fertavid treatment is then stopped and ovulation will be induced by giving human chorionic gonadotrophin (hCG).
Danish: Herefter afbrydes behandlingen med Fertavid, og ovulation kan induceres ved at administrere humant choriongonadotropin (hCG).
English: Usually, 7 to 14 days of treatment is sufficient to reach this state.
Danish: Sædvanligvis nås denne tilstand efter 7-14 dages behandling.
English: Primary Testicular Failure
Danish: Primær testikellidelse
English: Breast complaints include tenderness, pain and/or engorgement and nipple pain 2.
Danish: Brystgener inkluderer brystspænding, smerter og/eller brystforstørrelse samt smerte i brystvorterne 2.
English: This dose is continued for at least the first four days.
Danish: Denne dosis gives i mindst 4 dage.