FrancophonIA/ELRC3.0 huggingface dataset:
English: However the OHSS will only occur if hCG is also administered (see section 2, OHSS).
Danish: OHSS vil kun opstå, hvis hCG også indgives (se punkt 2, OHSS).
English: • Record this remaining dose in the ‘'Amount Set to Inject'' section in the next row (6).
Danish: • Registrer denne resterende dosis i punktet ”Indstillet injektionsvolumen” i næste række (6).
English: Example of a bad seal
Danish: Eksempel på en dårlig forsegling
English: Prescribed Dose
Danish: Ordineret dosis
English: • Repeat Section 3 (“Before you start using your GONAL-f pre-filled pen “) through Section 4 (“Getting your GONAL-f pre-filled pen ready for injection“) with a second pen.
Danish: • Gentag punkt 3 (”Inden du starter med at anvende GONAL-f fyldt pen”) til og med punkt 4 (”Klargøring af din GONAL-f fyldte pen til injektion”) med en ny pen.
English: Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4.
Danish: Man kan dog antage, at ovarielt hyperstimulationssyndrom (OHSS) indtræder, hvilket beskrives i punkt 4.
English: • Draw up some air into the syringe by pulling the plunger to approximately the 1 mL mark.
Danish: • Træk luft ind i injektionssprøjten ved at trække stemplet cirka til 1 ml mærket.
English: In rabbits, the formulation reconstituted with 0.9 % benzyl alcohol and 0.9 % benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single subcutaneous injection or mild inflammatory and degenerative changes after single intramuscular injection respectively.
Danish: Præparatet opløst med 0,9% benzylalkohol og i 0,9% benzylalkohol alene, injiceret i kaniner, resulterede i mindre blødninger og subakut inflammation efter en enkelt subkutan injektion eller i henholdsvis milde inflammatoriske og degenererende forandringer efter en enkelt intramuskulær injektion.
English: Any unused solution must be discarded.
Danish: Enhver form for ubrugt opløsning skal kasseres.
English: Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/LH is similar to that obtained with hMG.
Danish: Sammenligning med historiske data tyder på, at ovulationsraten med GONAL-f/LH ligner den, der opnås med hMG.
English: • Never reuse any used needle.
Danish: • En brugt kanyle må aldrig genbruges.
English: • If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Danish: • Hvis du er kvinde: med store æggestokke eller væskefyldte hulrum i æggestokkene (ovariecyster) af ukendt oprindelse.
English: If the peel-off seal is damaged or loose, do not use the needle.
Danish: Hvis den aftagelige forseglingsflig er beskadiget eller løs må kanylen ikke anvendes.
English: The medicine must be administered immediately after preparation.
Danish: Medicinen skal tages umiddelbart efter opløsning.
English: The first injection of GONAL-f should be performed under direct medical supervision.
Danish: Den første GONAL-f-injektion skal udføres under direkte medicinsk overvågning.
English: • Before starting the preparation, please read these instructions the whole way through first.
Danish: • Læs først hele denne vejledning, inden du starter forberedelsen.
English: • Take the syringe for injection and fill it with air by pulling the plunger to the correct dose in International Units (IU FSH).
Danish: • Tag injektionssprøjten og fyld den med luft ved at trække stemplet til den korrekte dosis i internationale enheder (IE FSH).
English: Water for injections Benzyl alcohol
Danish: Vand til injektionsvæsker Benzylalkohol
English: Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Danish: Behandling med GONAL-f skal administreres under opsyn af en læge, som har erfaring inden for behandling af fertilitetsforstyrrelser.
English: • For further injections with the prepared solution of GONAL-f, repeat steps 4. to 7.
Danish: • Ved flere injektioner med den opløste blanding af GONAL-f gentages trin 4 til 7.
English: This instructionsfor use was last revised in:
Danish: Denne brugsanvisning blev senest ændret:
English: Appearance of the solvent: clear colourless solution.
Danish: Solvensens udseende: Klar farveløs væske.
English: Getting your GONAL-f pre-filled pen ready for injection 4.1.
Danish: Klargøring af din GONAL-f fyldte pen til injektion 4.1.
English: If you do not see a tiny drop(s) at or near the needle tip the first time you use a new pen, you must perform the steps on the next page.
Danish: Hvis du ikke ser bittesmå dråber på eller nær ved kanylespidsen den første gang, du bruger en ny pen, skal du udføre trinene på den næste side.
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Danish: • forstørrede ovarier eller ovariecyste, som ikke er forårsaget af polycystisk ovariesyndrom
English: • An empty syringe for injection (see illustration below)
Danish: • En tom injektionssprøjte til injektion (se illustrationen herunder)
English: Appearance of the powder: white lyophilised pellet.
Danish: Pulverets udseende: Hvidt frysetørret pulver.
English: If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing, and that the patient be hospitalised and appropriate therapy be started.
Danish: Hvis svær OHSS opstår, skal evt. igangværende gonadotropinbehandling stoppes og patienten indlægges på hospital og passende behandling for OHSS påbegyndes.
English: In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Danish: Hos mænd med mangelfuld FSH vil samtidig administration af GONAL-f og hCG i mindst 4 måneder inducere spermatogenesen.
English: The reconstituted solution is stable for 28 days at or below 25°C.
Danish: Den rekonstituerede opløsning er stabil i 28 dage ved eller under temperaturer på 25 °C.
English: Example: • Your doctor/pharmacist will tell you how many pens you need to complete your treatment.
Danish: • Din læge/apotekspersonalet vil fortælle dig, hvor mange penne du skal bruge for at gennemføre din behandling.
English: Dose (IU)
Danish: Dosis (IE)
English: Never store the pen with the needle attached.
Danish: Opbevar aldrig pennen med kanylen påsat.
English: Any unused solution must be discarded not later than 28 days after first opening.
Danish: Al ubrugt opløsning skal kasseres senest 28 dage efter anbrud.
English: Removing the needle after each injection.
Danish: Fjern kanylen efter hver injektion
English: When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Danish: Når du gennemgår assisteret befrugtning eller stimulation af æggestokkene for at producere æg, er risikoen for en abort større hos dig end hos den gennemsnitlige kvinde.
English: Once the solution has been prepared, it may be stored for a maximum of 28 days.
Danish: Når medicinen er opløst, kan den opbevares i højst 28 dage.
English: Throw it away in a sharps disposal container.
Danish: Smid den ud i beholderen til skarpt affald.
English: How to use the GONAL-f pre-filled pen How to use your GONAL-f pre-filled pen Treatment diary Before you start using your GONAL-f pre-filled pen Getting your GONAL-f pre-filled pen ready for injection Setting the dose prescribed by your doctor Injecting the dose
Danish: Sådan skal du bruge GONAL-f fyldt pen Sådan skal du bruge dagbogen over behandling med GONAL-f fyldt pen Inden du starter med at anvende GONAL-f fyldt pen Klargøring af din GONAL-f fyldte pen til injektion Indstilling af dosis ordineret af lægen Injektion af dosis
English: GONAL-f should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
Danish: GONAL-f skal gives, samtidig med hCG, i doser på 150 IE 3 gange ugentligt i minimum 4 måneder.
English: If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen: 1.
Danish: Hvis du ikke ser bittesmå dråber af væske på eller nær ved spidsen den første gang, du bruger en ny pen: 1.
English: Example of a good seal
Danish: Eksempel på en god forsegling
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2-8°C).
English: • Record your prescribed dose in the ‘'Prescribed Dose'' section (5).
Danish: • Registrer din ordinerede dosis i punktet ”Ordineret dosis” (5).
English: Up to three containers of powder may be dissolved in 1 mL of solvent.)
Danish: Op til 3 beholdere med pulver kan opløses i 1 ml solvens).
English: Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
Danish: Data fra anvendelse af GONAL-f hos et begrænset antal gravide (mindre end 300 graviditetsudfald) indikerer ikke misdannelser eller føtal/neonatal toksicitet af GONAL-f.
English: 4.7 Effects on ability to drive and use machines GONAL-f is expected to have no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner GONAL-f forventes ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The pH of the reconstituted solution is 6.5-7.5.
Danish: Den rekonstituerede opløsning har en pH-værdi på 6,5-7,5.
English: • Check that the peel-off seal on the outer needle cap is not damaged or loose:
Danish: • Kontrollér, at den aftagelige forseglingsflig på den ydre kanylehætte ikke er beskadiget eller løs.
English: Follitropin alfa, 600 IU/mL (equivalent to 44 micrograms/mL)
Danish: Follitropin alfa, 600 IE/ml (svarende til 44 mikrogram/ml)
English: The prepared solution can be used for several injections.
Danish: Den tilberedte opløsning kan bruges til flere injektioner.
English: • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Danish: • OHSS kan blive alvorligt med tydeligt forstørrede æggestokke, nedsat urinproduktion, vægtøgning, åndedrætsbesvær og/eller mulig væskeophobning i maven eller brystkassen.
English: Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers safely preferably in the sharp container.
Danish: Bortskaffelse af alle de brugte ting: Straks efter at du har afsluttet injektionen, kasseres alle kanylerne og de tomme hætteglas på forsvarlig vis og helst i beholderen til skarpt affald.
English: • your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
Danish: • Hvis din hud bliver skrøbelig og let får blærer, specielt på steder, som ofte udsættes for sollys,
English: • Swirl gently the vial of GONAL-f prepared in step 3, do not shake.
Danish: • Sæt forsigtigt væsken i hætteglasset med GONAL-f, som blev forberedt i trin 3, i bevægelse, ryst ikke.
English: • The solvent is water for injections.
Danish: • Solvensen er vand til injektionsvæsker.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, therefore it is considered essentially “sodium-free”.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, d.v.s. den anses i det væsentlige for natriumfri.
English: • The solvent contains water for injections and benzyl alcohol.
Danish: • Solvensen indeholder vand til injektionsvæsker samt benzylalkohol .
English: No direct comparison of GONAL-f/LH versus human menopausal gonadotropin (hMG) has been performed.
Danish: Der er ikke fortaget nogen direkte sammenligning mellem GONAL-f/LH og humant menopausalt gonadotropin (hMG).
English: The effects of taking too much GONAL-f are unknown.
Danish: Virkningen af en overdosering af GONAL-f er ukendt.
English: Reproductive system and breast disorders Very common: Ovarian cysts Common:
Danish: Det reproduktive system og mammae Meget almindelig: Ovariecyster Almindelig:
English: Inject the dose as you were trained to do by your doctor or nurse.
Danish: Injicer dosis efter instruktion fra din læge eller sygeplejerske.
English: • together with another medicine called “lutropin alfa” (“Luteinising Hormone” or LH) to help release egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
Danish: • Sammen med en anden medicin, der kaldes “lutropin alfa” (“luteiniseringshormon” eller LH) til at hjælpe med at frigive æg fra æggestokken (ovariet) hos kvinder, som ikke har ægløsning, fordi deres krop producerer meget få gonadotropiner (FSH og LH).
English: Contains: 1 mL water for injections
Danish: Indeholder: 1 ml vand til injektionsvæsker.
English: • primary testicular insufficiency
Danish: • Primær testikelinsufficiens
English: * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: * rekombinant humant follikelstimulerende hormon (r-hFSH) produceret i ovarieceller fra kinesisk hamster (CHO) ved rekombinant DNA-teknologi.
English: If your doctor cannot see a desired response after 4 weeks, that treatment cycle with GONAL-f should be stopped.
Danish: Hvis din læge ikke kan se den ønskede virkning efter 4 uger, bør denne behandlingscyklus med GONAL-f stoppes.
English: Warning: Please read these instructions for use before using your GONAL-f pre-filled pen.
Danish: Advarsel: Læs denne brugervejledning, inden du starter med at anvende din GONAL-f fyldte pen.
English: There is no relevant use of GONAL-f in the elderly population.
Danish: Det er ikke relevant at anvende GONAL-f hos den ældre population.
English: • Store the glass vial with the prepared solution in a safe place.
Danish: • Opbevar hætteglasset med den tilberedte opløsning på et sikkert sted.
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Danish: Disse patienter er i kliniske studier blevet identificeret med et endogent LH-serum-niveau på <1,2 IE/l.
English: The prefilled pen can be used for several injections.
Danish: Den fyldte pen kan bruges til flere injektioner.
English: Setting the dose prescribed by your doctor
Danish: Indstilling af dosis ordineret af lægen
English: If your doctor cannot see a response after 5 weeks, that treatment cycle with GONAL-f should be stopped.
Danish: Hvis din læge ikke ser en virkning efter 5 uger, bør denne behandlingscyklus med GONAL-f stoppes.
English: • GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Danish: • GONAL-f sammen med en luteiniserende hormon (LH) opløsning anbefales til stimulation af follikeludvikling hos kvinder med svær mangel af LH og FSH.
English: • Your doctor or nurse will show you how to use the GONAL-f pre-filled pen to inject the medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du bruger GONAL-f fyldt pen til at injicere medicinen.
English: Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Danish: Der er rapporteret nedsat fertilitet hos rotter, som blev eksponeret for farmakologiske doser af follitropin alfa ( 40 IE/kg/dag) gennem længere perioder.
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Danish: Meget sjældent kan sværOHSS blive kompliceret af ovarietorsion eller tromboemboliske hændelser, som f.eks. lungeemboli, iskæmisk slagtilfælde og myokardieinfarkt.
English: Safety, efficacy and pharmacokinetics of GONAL-f in patients with renal or hepatic impairment have not been established.
Danish: Sikkerhed, virkning og farmakokinetik ved brug af GONAL-f hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
English: There is no relevant use of GONAL-f in the paediatric population.
Danish: Det er ikke relevant at anvende GONAL-f hos den pædiatriske population.
English: Do not use GONAL-f
Danish: Brug ikke GONAL-f
English: Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Danish: Hvis der opstår tegn på hyperstimulation af ovariet, f.eks. serumestradiol > 5.500 picog/ml eller > 20.200 picomol/l og/eller ≥ 40 follikler i alt, bør hCG seponeres og patienten tilrådes at afstå fra coitus eller bruge en sikker præventionsmetode i mindst 4 dage.
English: Safety and effectiveness of GONAL-f in elderly patients have not been established.
Danish: GONAL-f's sikkerhed og virkning hos ældre patienter er ikke klarlagt.
English: • If you see a tiny drop(s) of fluid proceed to Section 5: Setting the dose prescribed by your doctor.
Danish: • Hvis du ser bittesmå dråber væske, går du til punkt 5: Indstilling af dosis ordineret af lægen.
English: The maximum daily dose is 450 IU (0.72 mL).
Danish: Den maksimale daglige dosis er 450 IE (0,72 ml).
English: Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months at or below 25°C.
Danish: Før åbning og inden for holdbarhedstiden kan lægemidlet fjernes fra køleskabet, uden at blive nedkølet igen, i op til 3 måneder ved eller under temperaturer på 25 °C.
English: Such patients are unresponsive to GONAL-f/hCG therapy.
Danish: Hos sådanne patienter er der ingen respons på behandling med GONAL-f/hCG.
English: • If you administer GONAL-f to yourself, please carefully read and follow the instructions at the end of this leaflet called “How to prepare and use the GONAL-f powder and solution”.
Danish: • Hvis du selv injicerer GONAL-f, skal du læse og følge instruktionerne grundigt i slutningen af denne indlægsseddel i afsnittet: “Sådan skal du tilberede og tage GONAL-f pulver og solvens”.
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table below) and in ovulation induction, GONAL-f 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, der sammenlignede r-hFSH (follitropin alfa) og u-FSH i ART (se tabellen nedenfor) og i ovulationsinduktion, var GONAL-f mere potent end u-FSH i form af en lavere total dosis og en kortere behandlingsperiode til at udløse follikulær modning.
English: No other clinically significant medicinal product interaction has been reported during GONAL-f therapy.
Danish: Ingen klinisk signifikante interaktioner med andre lægemidler er rapporteret for GONAL-f.
English: GONAL-f is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Danish: GONAL-f er et potent gonadotropinpræparat som kan fremkalde lette til alvorlige bivirkninger, og bør derfor kun bruges af læger som er specialiseret i infertilitetsbehandling.
English: DATE OF RECONSTITUTION
Danish: DATO FOR REKONSTITUTION
English: • together with another medicine called “human Chorionic Gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
Danish: • Sammen med en anden medicin, som kaldes humant choriongonadotropin (hCG), til at hjælpe med at producere sæd hos mænd, som er ufrugtbare på grund af et lavt niveau af visse hormoner.
English: There is no indication for use of GONAL-f during pregnancy.
Danish: Der er ingen indikation for GONAL-f under graviditet.
English: • Remove the protective cap from the solvent vial.
Danish: • Fjern beskyttelseshætten fra hætteglasset med solvens.
English: • Do not use any GONAL-f solution left in the vial after 28 days.
Danish: • Brug ikke eventuelt ubrugt GONAL-f opløsning i hætteglasset efter 28 dage.
English: • The maximum daily dose of GONAL-f is usually not higher than 225 IU (0.36 mL).
Danish: • Den maksimale daglige dosis af GONAL-f er sædvanligvis ikke højere end 225 IE (0,36 ml).
English: • Remove the syringe from the vial and throw it away (put the protective cap to avoid injuries).
Danish: • Tag injektionssprøjten ud af hætteglasset og smid den ud (sæt beskyttelseshætten på injektionssprøjten for at undgå skader.
English: • Swelling of the veins above and behind the testicles (a varicocele).
Danish: • Opsvulmen af blodårerne over og bag testiklerne (årebrok i pungen).
English: • The powder is a white pellet in a glass vial.
Danish: • Pulveret er en hvid pellet i et hætteglas.
English: • GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Danish: • GONAL-f er indiceret til stimulation af spermatogenesen hos mænd, som har medfødt eller erhvervet hypogonadotrop hypogonadisme i kombination med behandling med humant choriongonadotropin (hCG).
English: Reservoir holder
Danish: Reservoirbeholder
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 C.
English: GONAL-f is expected to have no or negligible influence on the ability to drive and use machines.
Danish: GONAL-f forventes ikke eller kun i ubetydelig grad at påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: In women with anovulation, the object of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
Danish: Hos kvinder med anovulation er formålet med GONAL-f behandling at udvikle en enkelt moden Graafsk follikel, hvorfra oocyten frigøres efter administration af hCG.
English: For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
Danish: Man kan f.eks. efter to ugers behandling med en agonist, administrere 150-225 IE GONAL-f de 7 første dage.
English: • If you administer GONAL-f to yourself, please carefully read and follow the “Instructions for
Danish: • Hvis du selv injicerer GONAL-f, skal du læse og følge instruktionerne grundigt i ”Brugervejledning”.
English: • The Dose Feedback Window will indicate the missing amount you need to inject using a new pen.
Danish: • Skærmen med dosisfeedback vil vise det volumen, du skal injicere med en ny pen.
English: Clean the skin by wiping with an alcohol swab.
Danish: Rens huden ved at tørre af med en spritserviet.
English: As GONAL-f multidose is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.
Danish: Da GONAL-f multidosis er beregnet til flere injektioner, bør patienten modtage klar instruktion, for at undgå forkert brug af multidosis formuleringen.
English: GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: GONAL-f indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, d.v.s. den er i det væsentlige natriumfri.
English: Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Danish: Kliniske vurderinger tyder på, at de daglige doser, administrationsregimer og monitoreringsprocedurer bør være de samme som bruges i aktuel behandling med lægemidler, der indeholder FSH udvundet fra urin (u-FSH).
English: • to help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not respond to treatment with a medicine called “clomiphene citrate”.
Danish: • Til at hjælpe med at frigive et æg fra æggestokken (ovariet) hos kvinder, som ikke har ægløsning, og hos kvinder, som ikke har reageret på behandling med en medicin, der kaldes “clomifencitrat”.