FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that your hands and the items you use are as clean as possible.
Danish: Det er vigtigt, at dine hænder og de redskaber, du anvender, er så rene som muligt.
English: How much to use
Danish: Hvor meget du skal bruge
English: Assemble everything you need.
Danish: Saml alt, hvad du har brug for.
English: • Find a clean area and a flat surface.
Danish: • Find et rent område og en flad overflade.
English: The following dose regimen should be used:
Danish: Følgende dosisregimen bør anvendes:
English: • Gather everything you need and lay it out:
Danish: • Saml alt du har brug for og læg det frem:
English: It is best to put it back into its original package.
Danish: Det er bedst at lægge den tilbage i originalpakningen.
English: This is when your follicles develop too much and become large cysts.
Danish: Det vil sige, at dine follikler udvikler sig for meget, og bliver til store cyster.
English: This medicine may increase your risk of developing OHSS.
Danish: Denne medicin kan øge din risiko for at udvikle OHSS.
English: Do not use Ovitrelle if any of the above applies to you.
Danish: Brug ikke Ovitrelle, hvis en eller flere af ovennævnte tilstande gælder for dig.
English: Do not attempt to inject a second time.
Danish: Forsøg ikke at injicere en gang til.
English: OHSS was observed in approximately 4% of patients treated with Ovitrelle.
Danish: OHSS blev observeret hos ca. 4 % af de patienter, som blev behandlet med Ovitrelle.
English: • Feeling depressed, irritable or restless.
Danish: • Deprimeret, irritabel eller rastløs.
English: Take as much time as you need to inject all the solution.
Danish: Brug så meget tid, som du behøver, til at injicere hele opløsningen.
English: In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Danish: Hos disse kvinder skal fordelene ved behandling med gonadotropin vejes op mod risiciene.
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), not known (cannot be estimated from the available data).
Danish: De følgende definitioner gælder hyppighedsterminologien, der anvendes herefter: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The dose display will show a straight line and you have to keep turning until you can read the number ‘250'.
Danish: Dosisdisplayet vil vise en lige linje, og du skal fortsætte med at dreje, indtil du kan aflæse tallet ‘250'.
English: Multiple pregnancy and/or birth defects
Danish: Flerfoldsgraviditet og/eller fødselsdefekter
English: A comparative study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Danish: Et sammenligningsstudie mellem den frysetørrede formulering og den opløste formulering viste bioækvivalens mellem de to formuleringer.
English: • Extrauterine pregnancy in the previous 3 months
Danish: • Ekstrauterin graviditet inden for de seneste tre måneder
English: Stop using Ovitrelle and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at tage Ovitrelle og besøg straks lægen, hvis du bemærker en af de følgende alvorlige bivirkninger - du kan have behov for akut medicinsk behandling:
English: Multiple pregnancy may lead to medical complications for you and your babies.
Danish: Flerfoldsgraviditet kan resultere i medicinske komplikationer for dig og din nyfødte.
English: Interference with serum or urinary testing
Danish: Interferens med serum- eller urintestning
English: Inject under the skin, as you were taught.
Danish: Injicer under huden, som du har lært.
English: This shows that the complete dose was delivered.
Danish: Dette viser, at hele dosis blev leveret.
English: The effects of an overdose of Ovitrelle are unknown.
Danish: Virkningen af en overdosis Ovitrelle er ukendt.
English: • Verify the expiration date on the pen label.
Danish: • Kontrollér udløbsdatoen på pennens etiket.
English: Only clear solution without particles should be used.
Danish: Kun en klar opløsning uden partikler må anvendes.
English: • This confirms that the dose has been fully delivered.
Danish: • Dette bekræfter, at dosis var helt fuldført.
English: Clinical investigation in women for the indication of ART and anovulation was limited to one treatment cycle.
Danish: Kliniske undersøgelser hos kvinder for indikationen ART og anovulation er begrænset til en behandlingscyklus.
English: Children and adolescents Ovitrelle is not for use in children and adolescents.
Danish: Børn og unge Ovitrelle må ikke anvendes til børn og unge.
English: Severe OHSS was reported in less than 0.5% of patients (see section 4.4).
Danish: Alvorlig OHSS blev rapporteret hos færre end 0,5 % af patienterne (se pkt 4.4).
English: If you pass this position, simply turn the dose setting knob back to the dot (●).
Danish: Hvis du drejer forbi denne position, skal du blot dreje dosisindstillingsknappen tilbage til prikken (●).
English: Setting the dose to 250”).
Danish: Indstilling af dosis til 250”).
English: • Anovulatory or oligo-ovulatory women:
Danish: • Anovulatoriske eller oligo-ovulatoriske kvinder:
English: • Local reactions at the injection site, such as pain, redness or swelling.
Danish: • Lokale reaktioner på injektionsstedet, såsom smerte, rødmen og hævelse.
English: Studies on carcinogenic potential were not performed.
Danish: Der er ikke udført undersøgelser af karcinogenicitet.
English: If you do not see any liquid, you may try a second time (you may do this a maximum of two times) starting from step 1 of section “If you do not see a tiny drop(s) of fluid at or near the tip” above.
Danish: Hvis du ikke ser nogen væske, kan du forsøge en gang til (du kan højst gøre dette to gange) startende fra trin 1 i punktet ”Hvis du ikke ser bittesmå dråber af væske på eller nær ved spidsen” ovenfor.
English: When using Ovitrelle, you have a higher risk of being pregnant with more than one child at the same time (‘multiple pregnancy', usually twins) than if you conceived naturally.
Danish: Når du anvender Ovitrelle, har du en højere risiko for at blive gravid med mere end et barn samtidig (flerfoldsgraviditet, sædvanligvis tvillinger) end hvis du blev naturligt gravid.
English: Any unused solution must be discarded.
Danish: Al ubrugt opløsning skal kasseres.
English: No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Danish: Der er ikke foretaget nogen reproduktionsstudier med choriongonadotropin alfa på dyr (se pkt 5.3).
English: There is no indication for the use of Ovitrelle during pregnancy.
Danish: Der er ingen indikation for anvendelse af Ovitrelle under graviditeten.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely.
Danish: • Alvorlige blodpropkomplikationer (tromboemboliske hændelser), nogle gange uafhængig af OHSS, kan meget sjældent ses.
English: Paediatric population There is no relevant use of Ovitrelle in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende Ovitrelle hos den pædiatriske population.
English: • The dose display should show “250”, shown in the figure below.
Danish: • Dosisdisplayet skal vise “250”, som vist på figuren nedenfor.
English: Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Danish: Selvadministration af Ovitrelle bør kun udføres af patienter, som har fået tilstrækkelig træning og har adgang til ekspertrådgivning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 February 2001
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 02. februar 2001 Dato for seneste fornyelse: 02. februar 2006
English: There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions); therefore, Ovitrelle is not indicated in these conditions.
Danish: Der er ingen klinisk erfaring med Ovitrelle i behandlingen af andre tilstande (såsom corpus luteum insufficiens eller mandlige tilstande) og Ovitrelle er derfor ikke indiceret til disse tilstande.
English: 5.3 Verify once more that the number in the dose display reads ‘250'.
Danish: 5.3 Kontrollér igen, at tallet, som vises på dosisdisplayet viser ‘250'.
English: • In case the dose display doesn't show 0, please contact your doctor or pharmacist.
Danish: • I tilfælde af, at dosisdisplayet ikke viser 0, skal du kontakte lægen eller apoteket.
English: Do not use Ovitrelle
Danish: Brug ikke Ovitrelle
English: These are considered concomitant effects related to assisted reproductive techniques.
Danish: Disse anses for at være samtidige virkninger, der er relateret til behandling med assisteret befrugtning.
English: It must be discarded if not used after these 30 days.
Danish: Lægemidlet skal kasseres, hvis det ikke er blevet anvendt inden disse 30 dage.
English: Dispose of all used items:
Danish: Kassér alle brugte redskaber:
English: So far, there are no signs of antibody development in humans to Ovitrelle.
Danish: Indtil videre findes ikke nogle tegn på antistof udvikling hos mennesker mod Ovitrelle.
English: Use each needle and pen only once.
Danish: Brug kun hver kanyle og pen én gang.
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Danish: Dette menes at være på grund af forskelle i forældrenes karakteristik (f.eks. moderens alder, sædkarakteristika) og den større forekomst af flerfoldsgraviditet.
English: • The dose number shown in the dose display will turn back to ‘0'.
Danish: • Dosisnummeret vist på dosisdisplayet vil dreje tilbage til ‘0'.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/165/008
English: If you are developing OHSS, 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, kan du få at vide, at du bør undgå samleje eller at du bør anvende barriereprævention i mindst 4 dage.
English: Before the treatment is started, your and your partner's fertility should be evaluated by a doctor experienced in the treatment of fertility problems.
Danish: Før behandlingen startes, skal din og din partners fertilitet vurderes af en læge, der har erfaring med behandlingen af fertilitetsproblemer.
English: What Ovitrelle is used for Ovitrelle is used together with other medicines:
Danish: Ovitrelle anvendes sammen med andre lægemidler:
English: • Ovarian, uterine or mammary carcinoma
Danish: • Ovarie-, uterus- eller mammakarcinom
English: • Do not push or pull the dose setting button while you turn it.
Danish: • Du må ikke trykke på eller trække i dosisindstillingsknappen når du drejer på den.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/165/007
English: Very rare (may affect up to 1 in 10,000 people) • Mild skin allergic reactions such as rash.
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer) • Milde overfølsomhedsreaktioner på huden, såsom udslæt.
English: Ask your doctor or pharmacist how to get a new needle.
Danish: Spørg lægen eller apotekspersonalet, hvordan du får en ny kanyle.
English: • Be careful not to prick yourself with the needle.
Danish: • Vær forsigtig, så du ikke stikker dig på kanylen.
English: • if you are allergic to choriogonadotropin alfa or any of the other ingredients of this medicine
Danish: • Hvis du er allergisk over for choriongonadotropin alfa eller et af de øvrige indholdsstoffer i
English: • Headache, feeling tired.
Danish: • Hovedpine, træthedsfølelse.
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: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Danish: Hos kvinder med nylig eller eksisterende tromboembolisk sygdom eller hos kvinder med generelt anerkendte risikofaktorer over for tromboemboliske hændelser, såsom personlig eller familieanamnese, behandling med gonadotropiner, kan yderligere øge risikoen for forværring eller forekomst af sådanne hændelser.
English: • Gynaecological haemorrhages of unknown aetiology
Danish: • Gynækologiske blødninger af ukendt ætiologi
English: • Fibroid tumours of the uterus incompatible with pregnancy
Danish: • Fibromer i uterus, der er uforenelige med graviditet
English: • Allergic reactions such as fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, or serious breathing difficulty are very rare (may affect up to 1 in 10,000 people).
Danish: • Overfølsomhedsreaktioner såsom hurtig eller uregelmæssig puls, hævelse af tunge og hals, nysen, hiven efter vejret eller alvorlige vejrtrækningsproblemer er meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer).
English: Therefore, your doctor should perform an early ultrasound examination to rule out the possibility of pregnancy outside the womb.
Danish: Derfor bør din læge udføre en ultralydsundersøgelse for at udelukke muligheden for en graviditet uden for livmoderen.
English: If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result.
Danish: Hvis du får taget en graviditetstest med serum eller urin efter anvendelse af Ovitrelle og op til ti dage efter, kan det forekomme, at du får et falsk positivt testresultat.
English: 5.1 Choose the injection site in the area your doctor or nurse has told you to give the injection.
Danish: 5.1 Vælg et injektionssted i det område, din læge eller sygeplejerske har anvist dig at give injektionen i.
English: Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. age) may also be associated with an increased chance of birth defects.
Danish: Flerfoldsgraviditet og specifikke karakteristika af parrene med fertilitetsproblemer (f.eks. alder) kan være associeret med en forhøjet risiko for fødselsdefekter.
English: Warning: Please read these instructions for use before using your Ovitrelle pre-filled pen.
Danish: Advarsel: Læs denne brugervejledning, inden du starter med at anvende din Ovitrelle fyldte pen.
English: To minimise the risk of OHSS, ultrasonographic assessments of follicular development and/or determination of serum estradiol levels should be performed prior to treatment and at regular intervals during treatment.
Danish: For at minimere risikoen for OHSS skal der udføres ultrasonografiske bedømmelser af follikulær udvikling og/eller serum-østradiolniveauerne skal bestemmes før behandling og med regelmæssige mellemrum under behandlingen.
English: Patients undergoing ovarian stimulation are at an increased risk of developing OHSS due to multiple follicular development.
Danish: Patienter, som modtager ovariestimulation, har en øget risiko for at udvikle OHSS forårsaget af multipel follikeludvikling.
English: • Check that the peel-off seal on the outer needle cap is not damaged or loose.
Danish: • Kontrollér, at den aftagelige forsegling på den ydre kanylebeskytter ikke er beskadiget eller løs.
English: However, the in-use stability has been demonstrated for 24 hours at + 2°C to 8°C.
Danish: Stabiliteten af det opløste lægemiddel er blevet påvist til 24 timer ved 2 °C-8 °C.
English: This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Danish: Dette kunne resultere i brystsmerter, stakåndethed, slagtilfælde eller hjerteanfald (se også i punkt 2 under 'Problemer med blodpropper (tromboemboliske hændelser)').
English: This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
Danish: Dette er begrundet da det aktive stof er et protein, og da resultaterne af genotoksicitets-tests var negative.
English: The steady-state volume of distribution and the total clearance are 6 l and 0.2 L/h, respectively.
Danish: Steady-state fordelingsvolumen og samlet clearance er hhv. 6 l og 0,2 l/t.
English: Since infertile women undergoing ART, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased.
Danish: Da infertile kvinder, der gennemgår assisteret befrugtning, og især IVF, ofte har unormale æggeledere, kan forekomsten af ektopisk graviditet være forhøjet.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA08
Danish: Farmakoterapeutisk klassifikation: Kønshormoner og modulatorer af kønsorgansystemet, gonadotropiner, ATC-kode: G03GA08.
English: There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
Danish: Der forefindes intet tegn på at choriongonadotropin alfa metaboliseres og udsondres anderledes end endogent hCG.
English: The rate of miscarriage, in both anovulatory patients and women undergoing assisted reproductive techniques, is higher than that found in the normal population but comparable with the rates observed in women with other fertility problems.
Danish: Hyppigheden af spontane aborter, både for anovulatoriske patienter og kvinder, der gennemgår assisteret befrugtning, er højere end i normalpopulationen, men sammenlignelig med hyppigheden hos kvinder med andre fertilitetsproblemer.
English: Posology The maximum dose is 250 micrograms.
Danish: Dosering Den maksimale dosis er 250 mikrogram.
English: If you forget to use Ovitrelle If you forget to use Ovitrelle, please talk to your doctor as soon as you notice.
Danish: Hvis du har glemt at bruge Ovitrelle Hvis du har glemt at bruge Ovitrelle, skal du kontakte lægen så snart du bemærker det.
English: How to use your Ovitrelle pre-filled pen Before you start using your Ovitrelle pre-filled pen Getting your Ovitrelle pre-filled pen ready for injection Setting the dose - “How to set the dose to 250” Injecting the dose
Danish: Sådan skal du bruge din Ovitrelle fyldte pen Inden du starter med at anvende din Ovitrelle fyldte pen Klargøring af din Ovitrelle fyldte pen til injektion Indstilling af dosis - “Sådan indstilles dosis til 250” Indsprøjtning af dosis
English: INFORMATION IN BRAILLE ovitrelle 250 pen
Danish: INFORMATION I BRAILLESKRIFT ovitrelle 250 pen
English: • The pen is for subcutaneous injection only.
Danish: • Pennen er kun til subkutan injektion.
English: Adherence to recommended Ovitrelle dose, regimen of administration and careful monitoring of therapy will minimise the risk of OHSS and multiple pregnancy.
Danish: Overholdelse af anbefalingerne vedrørende dosering og administrationsregime for Ovitrelle samt omhyggelig monitorering af behandlingen reducerer risikoen for OHSS og flerfoldsgraviditet til et minimum.
English: If you are not sure, talk to your doctor before using this medicine.
Danish: Er du i tvivl, så kontakt lægen, før du bruger dette lægemiddel.
English: Setting the dose to 250
Danish: Indstilling af dosis til 250
English: It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Danish: Det bør imidlertid bemærkes, at selve graviditeten samt OHSS også indebærer en øget risiko for tromboemboliske hændelser, såsom lungeemboli, iskæmisk slagtilfælde eller myokardieinfarkt.
English: Via delle Magnolie 15 70026 Modugno (Bari) Italy
Danish: Via delle Magnolie 15 70026 Modugno (Bari) Italien
English: Ovitrelle is for single use only.
Danish: Ovitrelle er kun til engangsbrug.
English: OHSS due to excessive ovarian response can be avoided by withholding hCG administration.
Danish: OHSS på grund af overdreven ovarierespons kan undgås ved at seponere behandlingen med hCG.
English: It is important to have early ultrasound confirmation that a pregnancy is intrauterine, and to exclude the possibility of extrauterine pregnancy.
Danish: Det er vigtigt at have en tidlig bekræftelse på, at graviditeten er intrauterin, via ultralydsscanning, og udelukke muligheden for en ekstrauterin graviditet.
English: Before you start using your Ovitrelle pre-filled pen
Danish: Inden du starter med at anvende din Ovitrelle fyldte pen
English: When undergoing Assisted Reproductive Techniques 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 dine æggestokke til at producere æg, er det mere sandsynligt, at du får en ufrivillig abort end den gennemsnitlige kvinde.
English: Nevertheless, there is a possibility that OHSS may result from an overdose of Ovitrelle (see section 4.4).
Danish: Ikke desto mindre er der en mulighed for, at en overdosis kan medføre OHSS (se pkt 4.4)
English: Ovitrelle contains sodium
Danish: Ovitrelle indeholder natrium
English: If you are not sure, talk to your doctor.
Danish: Hvis du er usikker, bedes du kontakte lægen.
English: • Malformations of sexual organs incompatible with pregnancy
Danish: • Gonademisdannelse, der er uforenelig med graviditet
English: Ovitrelle is expected to have no or negligible influence on the ability to drive and use machines.
Danish: Det forventes, at Ovitrelle ikke eller kun i ubetydelig grad påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: If the peel-off seal is damaged or loose, do not use the needle.
Danish: Hvis den aftagelige forsegling er beskadiget eller løs, må kanylen ikke anvendes.
English: Do not inject directly into a vein.
Danish: Injicer ikke direkte ind i en blodåre.
English: Fertility Ovitrelle is indicated for use in infertility (see section 4.1).
Danish: Fertilitet Ovitrelle er indiceret til anvendelse ved ufrugtbarhed (se pkt 4.1)
English: • To help develop and ripen several follicles (each containing an egg) in women undergoing Assisted Reproductive Techniques (procedure that may help you to become pregnant) such as ‘in vitro fertilisation'.
Danish: • Til at hjælpe med at udvikle og modne flere follikler (der hver indeholder et æg) til kvinder, som gennemgår assisteret befrugtning (procedure, der hjælper dig med at blive gravid) som f.eks. 'in vitro fertilisering' (IVF).
English: • if you have a tumour in a part of your brain called the ‘hypothalamus' or ‘pituitary gland'.
Danish: • Hvis du har en tumor i en del af hjernen kaldet hypotalamus eller hypofysen
English: In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Danish: Især skal patienten undersøges for hypotyreoidisme, adrenokortikal insufficiens, hyperprolaktinemi og tumorer i hypofyse eller hypotalamus, og adækvat behandling skal ydes.
English: • To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs (‘anovulation'), or women who produce too few eggs (‘oligo-ovulation').
Danish: • Til at hjælpe med at fremkalde ægløsning (ovulationsinduktion) hos kvinder, der ikke kan producere æg (en tilstand, der kaldes anovulation), eller hos kvinder, der producerer for få æg (oligo-ovulation).