FrancophonIA/ELRC3.0 huggingface dataset:
English: Packaging Content Package size
Danish: Emballage Indhold Pakningsstørrelse
English: You may need it again.
Danish: Du kan få brug for det igen.
English: Date of latest renewal: 20 October 2010.
Danish: Dato for seneste fornyelse: 20. oktober 2010.
English: The larger the dose, the longer it will take to inject.
Danish: Jo større dosis, jo længere vil det tage at injicere.
English: • It is important that your hands and the items you use be as clean as possible.
Danish: • Det er vigtigt, at dine hænder og de ting, som du anvender er så rene som muligt.
English: Need to increase the dose (%)
Danish: Behovet for at øge dosis (%)
English: •Wash your hands with soap and water.
Danish: •Vask dine hænder med sæbe og vand.
English: • Give yourself the injection at the same time each day.
Danish: • Giv dig selv injektionen på samme tidspunkt hver dag.
English: Wash your hands and find a clean area
Danish: Vask dine hænder og find et rent område
English: E - 28760 Tres Cantos (Madrid) Spain
Danish: E - 28760 Tres Cantos (Madrid) Spanien
English: Follow the procedure exactly, as it may differ from your past experience.
Danish: Følg proceduren nøje, da den kan være forskellig fra din tidligere anvendelse.
English: • A good place is a clean table or kitchen surface.
Danish: • Et godt sted er et rent bord eller køkkenbord.
English: EXP Shelf-life after first use: 28 days
Danish: EXP Opbevaringstid efter første anvendelse: 28 dage
English: Put it aside for later use.
Danish: Sæt den til side til senere brug.
English: • If you are a man: with damaged testicles that cannot be healed.
Danish: •Hvis du er mand: med beskadigede testikler, som ikke kan kureres.
English: An example of a treatment diary:
Danish: Et eksempel på en dagbog over behandlingen:
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Danish: Efter subkutan anvendelse er den absolutte biotilgængelighed ca. 70%.
English: The next injection should be done at the same time the next day.
Danish: Den næste injektion skal gives på samme tidspunkt næste dag.
English: • Record the treatment day number (1), date (2) and time (3) of your injection.
Danish: • Registrer nummeret på behandlingsdagen (1), dato (2) og tidspunkt (3) for din injektion.
English: The following table states the volume to be administered to deliver the prescribed dose:
Danish: Den følgende tabel angiver det volumen, der skal administreres, for at give den ordinerede dosis:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 1995.
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20. oktober 1995.
English: Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Danish: Pga. en lokal reaktion over for benzylalkohol, skal det samme injektionssted ikke anvendes på hinanden følgende dage.
English: Complete a partial injection (only when needed).
Danish: Udfør en delvis injektion (kun ved behov)
English: Get a new needle.
Danish: Tag en ny kanyle.
English: • GONAL-f is usually given every day.
Danish: • GONAL-f gives normalt dagligt.
English: Therefore patients should be followed for at least two weeks after hCG administration.
Danish: Derfor skal patienten følges i mindst 2 uger efter hCG administration.
English: The following definitions apply to the frequency terminology used hereafter: 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).
Danish: Følgende definitioner gælder for den herefter anvendte terminologi for hyppighed: 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).
English: Not provided in the pack:
Danish: Medfølger ikke i pakningen:
English: Gonadotropins are involved in reproduction and fertility.
Danish: Gonadotropiner har indvirkning på reproduktion og fertilitet.
English: The product must be discarded if it has not been used after 3 months.
Danish: Produktet skal kasseres, hvis det ikke er anvendt inden 3 måneder.
English: Warning: Always make sure to use a new needle for each injection.
Danish: Advarsel: Sørg altid for at anvende en ny kanyle til hver injektion.
English: Do not inject directly into a vein.
Danish: Injicer ikke direkte ind i en vene.
English: You can reduce the risk of multiple pregnancy by using the right dose of GONAL-f at the right times.
Danish: Du kan nedsætte risikoen for flerfoldsgraviditet ved at tage den rette dosis GONAL-f på de rette tidspunkter.
English: For immediate and single use following first opening and reconstitution.
Danish: Til engangsbrug umiddelbart efter åbning og rekonstitution.
English: •Find a clean area and aflat surface.
Danish: •Find et rent område og en flad overflade.
English: • You will use these two medicines three times a week for at least 4 months.
Danish: • Du skal bruge disse to lægemidler tre gange om ugen i mindst 4 uger.
English: •Gather everything you need and lay it out:
Danish: • Saml alt du har brug for og læg det frem:
English: Do not use GONAL-f if any of the above applies to you.
Danish: Brug ikke GONAL-f, hvis noget af ovenstående gælder for dig.
English: • Your asthma may get worse
Danish: • Din astma kan forværres
English: Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Danish: Studier har vist, at disse to lægemidler kan blandes og injiceres sammen, uden at nogen af lægemidlerne tager skade af det.
English: Removing air bubbles
Danish: Fjernelse af luftbobler
English: After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Danish: Når pulveret er opløst (hvilket normalt sker øjeblikkeligt), kontrolleres det, at opløsningen er klar og ikke indeholder nogen partikler.
English: Studies have shown that co-administration with lutropin alfa, does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Danish: Studier har vist, at indgivelse sammen med lutropin alfa ikke signifikant ændrer aktivitet, stabilitet, farmakokinetik eller farmakokinetiske egenskaber af de aktive stoffer.
English: A sticker will be added to allow the patient to write the day of first use.
Danish: Der vil blive vedlagt en etiket, hvor patienten kan skrive første anvendelsesdato.
English: The injection site should be alternated daily.
Danish: Injektionsstedet skal skiftes dagligt.
English: Do not touch the needle and do not allow the needle to touch any surface.
Danish: Vær omhyggelig med ikke at berøre kanylen og lad ikke kanylen røre ved nogen overflader.
English: Get together everything you need and lay them out:
Danish: Saml alt du har brug for og læg det frem:
English: A treatment diary is included on the last page.
Danish: Der medfølger en dagbog over behandlingen på den sidste side.
English: It is not expected that this medicine will affect your ability to drive and use machines.
Danish: Det forventes ikke, at denne medicin vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: • you have stomach, arm or leg pain.
Danish: • Hvis du har smerter i maven, arme eller ben.
English: Do not use GONAL-f if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
Danish: Brug ikke GONAL-f, hvis du bemærker synlige tegn på nedbrydning, hvis væsken indeholder partikler eller er uklar.
English: • Store the pen in its original packaging in a safe place.
Danish: • Opbevar pennen i den originale pakning på et sikkert sted.
English: Never share needles.
Danish: Kanyler må aldrig deles.
English: However, since GONAL-f is not indicated in pregnancy, these data are of limited clinical relevance.
Danish: Eftersom GONAL-f ikke er indiceret under graviditet, er disse data dog af begrænset klinisk relevans.
English: GONAL-f must not be used when an effective response cannot be obtained, such as:
Danish: GONAL-f må ikke anvendes når effektivt respons ikke kan opnås, som for eksempel:
English: Push the plunger until the air bubbles are gone.
Danish: Tryk på stemplet, indtil luftboblerne er væk.
English: • ovarian, uterine or mammary carcinoma
Danish: • ovarie-, uterus- eller mammakarcinom
English: • When the pen is empty, ask your pharmacist how to dispose of it.
Danish: • Når pennen er tom skal du spørge på apoteket, hvordan du skal aflevere den.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Danish: Det kan give brystsmerter, stakåndethed, slagtilfælde eller hjerteslag (se også i punkt 2 under ”Problemer med blodpropper”).
English: Verify a complete injection.
Danish: Kontrollere en fuldstændig injektion.
English: You can turn the dose knob backwards if you turn it past 25.
Danish: Du kan dreje dosisknappen tilbage, hvis du drejer forbi 25.
English: If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Danish: Hvis du udvikler OHSS, vil din læge måske ikke give hCG i denne behandlingscyklus, og du vil muligvis blive bedt om ikke at have samleje eller at bruge barriereprævention i mindst 4døgn.
English: • Slowly push the needle into the skin entirely (1).
Danish: • Tryk forsigtigt kanylen helt ind i huden (1).
English: • if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
Danish: • hvis du har en tumor i hypothalamus eller hypofysen (begge er dele af hjernen)
English: GONAL-f usually does not work if you have this problem.
Danish: GONAL-f er normalt ikke effektivt, hvis du har dette problem.
English: • If you have irregular periods, start using GONAL-f within the first 7 days of your menstrual cycle.
Danish: • Hvis du har uregelmæssig menstruation, skal du starte med at tage GONAL-f inden for de første 7 dage af din menstruationscyklus.
English: See the “Instructions for Use”.
Danish: Se “Brugervejledning”.
English: • Continue by pushing the capped needle against a firm surface until you hear a “click.”
Danish: • Fortsæt med at trykke kanylen med hætten mod en fast overflade, indtil du hører et ”klik” (click).
English: Using your treatment diary to record your daily injection(s) allows you to verify every day that you received the full prescribed dose.
Danish: Ved at anvende din dagbog over behandlingen til at registrere din(e) daglig(e) injektion(er) er du i stand til hver dag at verificere, at du får hele den ordinerede dosis.
English: Men with hypogonadotrophic hypogonadism
Danish: Mænd med hypogonadotrop hypogonadisme
English: When using GONAL-f, you have a higher risk of being pregnant with more than one child at the same time (“multiple pregnancy”, mostly twins), than if you conceived naturally.
Danish: Når du tager GONAL-f, har du en højere risiko for at blive gravid med flere end et foster ad gangen (”flerfoldsgraviditet”, i de fleste tilfælde tvillinger), end hvis du bliver gravid ad naturlig vej.
English: If you are not ovulating, having no periods and have been diagnosed with very low levels of FSH and LH hormones
Danish: Hvis du ikke har ægløsning og ikke får menstruationer, og du er blevet diagnosticeret med meget lave niveauer af FSH- og LH-hormoner
English: Table: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of GONAL-f with urinary FSH in assisted reproduction technologies)
Danish: Tabel: Resultaterne af studie GF 8407 (randomiseret parallelgruppestudie, der sammenligner virkningen og sikkerheden af GONAL-f versus FSH udvundet fra urin ved assisteret reproduktionsteknologi).
English: Therefore, it is considered appropriate to give a lower total dose of GONAL-f than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation.
Danish: Derfor anses det for hensigtmæssigt at give en lavere total dosis af GONAL-f end normalt anvendt ved u-FSH, ikke kun med henblik på at optimere follikeludviklingen, men også for at minimere risikoen for uønsket ovariehyperstimulation.
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this medicine (see section 4).
Danish: Hvis du får smerter i den nederste del af underlivet, tager meget hurtigt på i vægt, føler dig utilpas eller kaster op, eller hvis du har åndedrætsbesvær, skal du straks tale med lægen, som kan bede dig om at holde op med at tage medicinen (se punkt 4).
English: Verify you have given a complete injection.
Danish: Kontrollér, at du har givet en fuldstændig injektion
English: • fibroid tumours of the uterus incompatible with pregnancy
Danish: • fibroide tumorer i uterus uforenelige med graviditet.
English: Treatment in men Immune system disorders Very rare:
Danish: Behandling af mænd Immunsystemet Meget sjælden:
English: The prepared solution is for your use alone and must not be given to other patients.
Danish: Den tilberedte opløsning er kun til dit eget brug og må ikke gives til andre.
English: In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
Danish: I dette tilfælde skal lutropin alfa rekonstitueres først og derefter bruges til at rekonstituere GONAL-f pulveret.
English: If you are not ovulating and have irregular or no periods.
Danish: Hvis du ikke har ægløsning, og du har uregelmæssig eller ingen menstruation
English: Take as much time as you need to inject all the solution.
Danish: Brug så meget tid, som du behøver til at injicere al opløsningen.
English: For in-use storage conditions, see section 6.3.
Danish: Opbevaring efter anbrud, se punkt 6.3.
English: • GONAL-f dose may be increased, depending on your response.
Danish: • GONAL-f-dosis kan øges, afhængigt af den virkning, du opnår.
English: • Verify you dialed the right dose before injecting (6).
Danish: • Kontrollér, at du indstillede den korrekte dosis før injektion (6).
English: • This vial contains several doses of GONAL-f. You will have to keep it several days and only draw the prescribed dose every day.
Danish: • Dette hætteglas indeholder flere doser af GONAL-f. Du skal opbevare dette hætteglas i flere dage og kun tage den ordinerede dosis hver dag.
English: • gynaecological haemorrhages of unknown aetiology
Danish: • gynækologiske blødninger af ukendt ætiologi
English: • Your doctor or nurse will show you how to inject GONAL-f before you can inject yourself.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du indsprøjter GONAL-f, før du kan injicere dig selv.
English: • Hold the dose knob down for a minimum of 5 seconds to ensure you inject the full dose (2).
Danish: • Hold dosisknappen nede i mindst 5 sekunder for at sikre, at du injicerer hele dosis (2).
English: • In the first line of the table the volume of your pen is already recorded for you (4).
Danish: • Voluminet af din pen er allerede registreret for dig på den første linje i tabellen (4).
English: • 1 needle for preparation
Danish: • En kanyle til tilberedning
English: Switzerland or
Danish: Schweiz eller
English: Volume to be injected (mL)
Danish: Volumen, der skal injiceres (ml)
English: Follitropin alfa is a type of “Follicle Stimulating Hormone” (FSH) which belongs to the family of hormones called “gonadotropins”.
Danish: Follitropin alfa er en type "follikelstimulerende hormon" (FSH), som hører til den familie af hormoner, der kaldes "gonadotropiner".
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f.
Danish: Patienter med porfyri eller med porfyri i familieanamnesen skal monitoreres nøje under behandlingen med GONAL-f.
English: Do not use GONAL-f if you are pregnant or breast-feeding.
Danish: Brug ikke GONAL-f, hvis du er gravid eller ammer.
English: Use the treatment diary to record the amount of injected IUs you use each time.
Danish: Anvend dagbogen over behandlingen for at registrere det antal injicerede IE'er, som du bruger hver gang.
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also in section 2. under “Ovarian HyperStimulation Syndrome”).
Danish: Dette kan være tegn på, at æggestokkene har overreageret på behandlingen, og at der har udviklet sig store cyster i æggestokkene (se også i punkt 2 under ”Ovarielt hyperstimulationssyndrom”).
English: Then GONAL-f is started approximately two weeks after start of agonist treatment.
Danish: Dernæst startes GONAL-f ca. to uger efter start af agonistbehandling.
English: If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with GONAL-f treatment.
Danish: Hvis du tidligere eller for nylig har haft blodpropper i benene eller i lungerne, eller et hjerteanfald eller et slagtilfælde, eller hvis noget sådant er forekommet i din familie, kan du have en højere risiko for, at disse problemer opstår eller forværres med GONAL-f-behandlingen.
English: •Verify theexpiration dateon the pen label.
Danish: •Verificerudløbsdatoenpå pennens etiket.
English: • Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Danish: • Klem huden sammen og indfør kanylen i en 45 til 90 vinkel ved at anvende en dartlignende bevægelse.
English: If you notice any of the above-listed side effects you should immediately contact your doctor who might ask you to stop using GONAL-f.
Danish: Hvis du bemærker en eller flere af de ovenstående bivirkninger, skal du øjeblikkeligt kontakte lægen, som eventuelt vil bede dig om at holde op med at tage GONAL-f.
English: The pen is for subcutaneous injection only.
Danish: Pennen er kun til subkutan injektion.
English: If your doctor decides to try GONAL-f treatment, to monitor the treatment, they may ask you to provide semen for analysis 4 to 6 months after starting treatment.
Danish: Hvis din læge beslutter at prøve behandling med GONAL-f, vil du eventuelt blive bedt om at afgive sæd til analyse 4-6 måneder efter start af behandlingen for at overvåge behandlingen.
English: Read the dose remaining to be injected with a second pen.
Danish: Aflæse den resterende dosis, der skal injiceres med en ny pen.
English: Your doctor will have told you how many IUs to inject each day.
Danish: Din læge vil fortælle dig, hvor mange IE'er, du skal injicere hver dag.
English: Treatment Day Number
Danish: Nummer behandlings-dag
English: The GONAL-f and GnRH agonist are then both given until your follicles develop as desired.
Danish: GONAL-f og GnRH-agonist gives dernæst begge, indtil dine follikler udvikler sig som ønsket.
English: If you are not sure, talk to your doctor before using this medicine.
Danish: Er du i tvivl, så spørg lægen, inden du tager denne medicin.
English: • The first injection of GONAL-f should be given under supervision of your doctor.
Danish: • Den første injektion af GONAL-f skal gives under overvågning af din læge.
English: Proceed to Section 5: Setting the dose prescribed by your doctor.
Danish: Fortsæt til punkt 5: Indstilling af dosis ordineret af lægen.
English: • Inject under the skin by pushing gently the plunger, as you were taught.
Danish: • Injicer under huden ved at presse forsigtigt på stemplet, som du har lært.
English: GONAL-f should not be used when an effective response cannot be obtained.
Danish: GONAL-f må ikke anvendes, når der ikke kan opnås et effektivt respons.
English: • Do not use any medicine left in your pre-filled pen after 28 days.
Danish: • Brug ikke eventuelt ubrugt medicin i den fyldte pen efter 28 dage.
English: ONLY check for drop(s) the FIRST TIME you use a new GONAL-f pre-filled pen to remove air in the system.
Danish: Kontrollér KUN for dråber den FØRSTE GANG, du bruger en ny GONAL-f fyldt pen til at fjerne luft i systemet.
English: • Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Danish: • Injicer straks opløsningen: Din læge eller sygeplejerske vil allerede have rådgivet dig mht. hvor du skal injicere (f.eks. maven, forsiden af låret).
English: Set the dose that was prescribed by your doctor (in the example shown in the figure, it is 50 IU).
Danish: 5.3 Indstil den dosis, din læge ordinerede (i eksemplet vist på figuren er det 50 IE).
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Danish: Lutealfasestøtte bør overvejes idet mangel af substanser med luteotropisk aktivitet (LH/hCG) efter ovulation kan føre til for tidlig svigt af corpus luteum.
English: • malformations of sexual organs incompatible with pregnancy
Danish: • malformation af gonaderne, uforenelig med graviditet
English: In women, safe and effective use of GONAL-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Danish: Sikker og effektiv brug af GONAL-f hos kvinder, kræver overvågning af ovarierespons via ultralyd alene eller helst i kombination med regelmæssig måling af serumestradiol.
English: GONAL-f contains a medicine called “follitropin alfa”.
Danish: GONAL-f indeholder en form for medicin, som hedder "follitropin alfa".
English: Verify once more that the Dose Feedback Window displays the correct dose.
Danish: Kontrollér igen, at skærmen med dosisfeedback viser den korrekte dosis.
English: Warning: Check that the Dose Feedback Window displays your complete prescribed dose before you move on to the next step.
Danish: Advarsel: Kontroller at skærmen med dosisfeedback viser hele din ordinerede dosis, før du fortsætter med næste trin.
English: Warning: If the Dose Feedback Window shows a number higher than 0, the GONAL-f pre-filled pen is empty and you have not received your full prescribed dose.
Danish: Advarsel: Hvis skærmen med dosisfeedback viser et tal større end 0 er GONAL-f fyldte pen tom og du har ikke fået hele din ordinerede dosis.
English: The steady state volume of distribution and total clearance are 10 l and 0.6 l/h, respectively.
Danish: Steady statefordelingsrummet og den totale clearance er henholdsvis 10 liter og 0,6 liter/time.
English: Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Danish: Selvadministration af GONAL-f bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere kvalificeret fagpersonale.
English: • The numbers on the Dose Feedback Window are measured in International Units or IUs.
Danish: • Tallene på skærmen med dosisfeedback er målt i internationale enheder eller IE'er.
English: Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with GONAL-f compared with urinary FSH.
Danish: Sammenlignende kliniske studier har vist, at patienter gennemsnitligt har brug for en lavere kumulativ dosis og kortere behandlingsvarighed med GONAL-f sammenlignet med u-FSH.
English: • Set the dose to the missing amount you recorded in the treatment diary or the number still displayed in the Dose Feedback Window on your previous pen, and inject.
Danish: • Indstil dosis til den manglende mængde, som du registrerede i dagbogen over behandlingen eller det tal, der stadig vises på skærmen med dosisfeedback på din brugte pen og injicer.
English: • Get a new needle - only use the "single-use" needles supplied.
Danish: • Tag en ny kanyle - anvend kun de leverede kanyler ”til engangsbrug”.
English: 1 multidose pre-filled pen
Danish: 1 fyldt flerdosis pen
English: Warning:
Danish: Advarsel: