FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births (mostly twins) is increased compared with natural conception.
Danish: Hos patienter, der gennemgår ovulationsinduktion, er forekomsten af flerfoldsgraviditet og fødsler (mest tvillinger) øget sammenlignet med naturlig befrugtning.
English: Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
Danish: Efter subkutan injektion udskilles choriongonadotropin alfa fra kroppen med en terminal plasmahalveringstid på ca. 30 timer er den absolutte biotilgængelighed ca. 40%.
English: • If you see a tiny drop(s) of fluid proceed to Section 4: Setting the dose to 250.
Danish: • Hvis du ser bittesmå dråber væske, går du til punkt 4: Indstilling af dosis til 250.
English: • Lower abdominal pain together with nausea (feeling sick) or vomiting may be the symptoms of Ovarian Hyperstimulation Syndrome (OHSS).
Danish: • Smerter i nederste del af maven sammen med kvalme (utilpashed) eller opkastninger kan være symptomer på ovarielt hyperstimulationssyndrom (OHSS).
English: This instructions for use was last revised in:
Danish: Denne brugsanvisning blev senest ændret:
English: • Screw the threaded tip of the Ovitrelle pre-filled pen into the outer needle cap until you feel a light resistance.
Danish: • Skru gevindspidsen på Ovitrelle fyldt pen i den ydre kanylebeskytter, indtil du mærker en let modstand.
English: • Get a new needle - only use the ‘single use' needle supplied.
Danish: • Tag en ny kanyle - brug kun ”engangs”-kanylen, der følger med.
English: Do not use Ovitrelle if you are pregnant or breast-feeding.
Danish: Brug ikke Ovitrelle, hvis du er gravid eller ammer.
English: In comparative trials with different doses of Ovitrelle, the following adverse reactions were found to be associated with Ovitrelle in a dose-related fashion: OHSS, vomiting and nausea.
Danish: I sammenlignende undersøgelser med forskellige doser af Ovitrelle blev følgende dosisrelaterede bivirkninger fundet: OHSS, opkastning og kvalme.
English: Wipe the chosen area with an alcohol swab.
Danish: Tør det valgte område af med en spritserviet.
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing, do not give yourself the Ovitrelle injection and talk to your doctor straight away (see section 4).
Danish: Hvis du får smerter i den nederste del af maven, tager hurtigt på i vægt, er utilpas, kaster op eller får vejrtrækningsbesvær, må du ikke give dig selv en indsprøjtning med Ovitrelle og du skal straks kontakte lægen (se punkt 4).
English: It shares the amino acid sequence with urinary hCG. Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/CG receptor.
Danish: Det har samme aminosyresekvens som urinderiveret hCG. Choriongonadotropin binder til ovarielle theca- (og granulosa-) celler til en transmembran-receptor, der deles med det luteiniserende hormon, LH/CG-receptoren.
English: • If you administer Ovitrelle to yourself, please carefully read and follow the separate
Danish: • Hvis du selv skal administrere Ovitrelle, bedes du nøje læse og følge den “Brugsanvisning”,
English: 6.1 Check that the dose display shows ‘0'
Danish: 6.1 Kontrollér, at dosisdisplayet viser ‘0'.
English: • if you have cancer of your ovaries, womb or breast
Danish: • Hvis du har cancer i æggestokke, livmoder eller bryst
English: 6.2 Removing the needle after injection
Danish: 6.2 Fjern kanylen efter injektion
English: Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling med Ovitrelle skal foregå under vejledning af en speciallæge, der har erfaring med behandling af fertilitetsproblemer.
English: 6.3 Disposal
Danish: 6.3 Bortskaffelse
English: If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur.
Danish: Hvis du har brugt for meget Ovitrelle, er der en mulighed for, at ovarielt hyperstimulationssyndrom kan indtræde.
English: • if you have severe inflammation of your veins or blood clotting in your veins (active thromboembolic disorders).
Danish: • Hvis du har en alvorlig betændelsestilstand i venerne eller blodpropper i venerne (aktive tromboemboliske lidelser)
English: Pregnancy outside of the womb (an ectopic pregnancy) may occur in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb).
Danish: Graviditet uden for livmoderen (en ektopisk graviditet) kan forekomme hos kvinder med beskadigede æggeledere (de rør, der fører ægget fra æggestokkene til livmoderen).
English: INFORMATION IN BRAILLE ovitrelle 250/0.5 mL
Danish: INFORMATION I BRAILLESKRIFT ovitrelle 250/0,5 ml
English: Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration.
Danish: Der er rapporteret om ektopisk graviditet, ovarietorsion og andre komplikationer hos patienter efter injektion af hCG.
English: Choriogonadotropin alfa is similar to a hormone found naturally in your body called ‘chorionic gonadotropin', which is involved in reproduction and fertility.
Danish: Choriongonadotropin alfa ligner det hormon kaldet 'choriongonadotropin', der findes naturligt i din krop, som er involveret i reproduktion og frugtbarhed.
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 Ovitrelle treatment.
Danish: Problemer med blodpropper (tromboemboliske hændelser) Hvis du førhen eller for nyligt har haft en blodprop i benet eller i lungen eller et hjerteanfald eller slagtilfælde, eller hvis en fra familien har oplevet det, kan du have en højere risiko for, at disse problemer opstår eller bliver værre med Ovitrelle-behandlingen.
English: • Active thromboembolic disorders
Danish: • Aktiv tromboembolisk sygdom
English: • Ovitrelle is intended to be given by injection under the skin (subcutaneously).
Danish: • Ovitrelle er beregnet til at blive givet som en injektion under huden (subkutant).
English: Repeated exposure to Ovitrelle was investigated in male patients only.
Danish: Gentagen behandling med Ovitrelle er kun undersøgt hos mænd.
English: • Inject Ovitrelle as your doctor or nurse taught you.
Danish: • Injicer Ovitrelle som din læge eller sygeplejerske har instrueret dig.
English: Firmly pinch the skin together and insert the needle for injection at a 45° to 90° angle using a dart-like motion.
Danish: Klem fast om huden, og indfør nålen i en vinkel på 45° til 90° med en dart-lignende bevægelse.
English: Using this medicine
Danish: Sådan tages dette lægemiddel
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Danish: Før behandlingen påbegyndes, bør parrets infertilitet vurderes, og formodede kontraindikationer for graviditet skal evalueres.
English: • Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth.
Danish: • Anovulatoriske eller oligo-ovulatoriske voksne kvinder: Ovitrelle gives for at fremkalde ægløsning og luteinisering hos anovulatoriske eller oligo-ovulatoriske kvinder efter follikelstimulation.
English: • Postmenopausal women
Danish: • Post-klimakterielle kvinder
English: • Ovitrelle is intended for subcutaneous use that means given by injection under the skin.
Danish: • Ovitrelle er beregnet til subkutan anvendelse hvilket betyder, at det gives som en injektion under huden.
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 indikere, at ovarierne overreagerede på behandlingen, og at der har udviklet sig store cyster på æggestokkene (se også i punkt 2 under 'Ovarielt hyperstimulationssyndrom (OHSS)').
English: Pregnancy outside your womb, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted reproductive techniques your doctor may use.
Danish: Graviditet uden for livmoderen, ovarietorsion (en tilstand, der påvirker æggestokkene) og andre komplikationer kan opstå fra den assisterede befrugtning, som din læge anvender.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Poloxamer 188
Danish: Dinatriumphosphatdihydrat Natriumdihydrogenphosphatmonohydrat Poloxamer 188
English: In comparative clinical trials, administration of a dose of 250 micrograms of Ovitrelle was as effective as 5,000 IU and 10,000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive techniques, and as effective as 5,000 IU of urinary hCG in ovulation induction.
Danish: Sammenlignende kliniske afprøvninger viser at en dosis 250 mikrogram Ovitrelle er lige effektiv som 5.000 IE og 10.000 IE af urin-hCG for at inducere afsluttende follikel modning og tidlig luteinisering ved assisteret befrugtning og lige så effektiv som 5.000 IE urin-hCG ved ovulationsinduktion.
English: Other medicines will be given first to bring about the growth of several follicles.
Danish: Der anvendes først andre lægemidler, der medfører vækst af flere follikler.
English: If you administer Ovitrelle to yourself, please carefully read the following instructions: Wash your hands.
Danish: Hvis du selv skal administrere Ovitrelle, bedes du læse de følgende anvisninger nøje:
English: Please note: alcohol swabs and sharps disposal container are not provided in the pack.
Danish: Bemærk: Spritservietterne og beholderen til skarpt affald leveres ikke med pakningen.
English: The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
Danish: Hos kvinder er den primære farmakodynamiske aktivitet genoptagelse af oocyt-meiose, follikel-ruptur (ovulation), dannelse af corpus luteum og produktion af progesteron og østradiol via corpus luteum.
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 har allerede vejledt dig i, hvor du skal injicere (fx maven eller forsiden af låret).
English: • This pen is for single use only.
Danish: • Denne pen er kun til engangsbrug.
English: Therefore, if signs of ovarian hyperstimulation occur such as serum estradiol level > 5,500 pg/mL (20,000 pmol/L) and/or when there are 30 or more follicles in total, it is recommended to withhold hCG administration and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Danish: Hvis der forekommer tegn på hyperstimulation af ovarier, således at serumøstradiolniveauet er > 5.500 pg/ml (20.000 pmol/l) og/eller når der er 30 eller flere follikler i alt, anbefales det at seponere indgivelse af hCG og at patienten rådes til at undgå coitus eller at anvende barriereprævention i mindst 4 dage.
English: Ovitrelle is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth.
Danish: Ovitrelle bruges til at udløse follikelmodning og tidlig luteinisering efter brug af produkter der stimulerer follikelvækst.
English: The risk of multiple pregnancy following assisted reproductive techniques is related to the number of embryos replaced.
Danish: Risikoen for flerfoldsgraviditet ved assisteret befrugtning er relateret til antallet af embryoer, der lægges tilbage.
English: Gently turn the dose setting knob clockwise until you see a dot (●) in the dose display.
Danish: Drej forsigtigt dosisindstillingsknappen med uret, indtil du kan se en prik (●) foran på dosisdisplayet.
English: No clinical data on exposed pregnancies are available.
Danish: Der forefindes ikke nogen kliniske data i forbindelse med graviditet.
English: • if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs.
Danish: • Hvis du har en tilstand, som normalt gør en normal graviditet umulig, såsom overgangsalder, tidlig overgangsalder (ovariesvigt) eller misdannelser af kønsorganerne.
English: • Your doctor or nurse will show you how to use the Ovitrelle pre-filled pen to inject the medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du bruger Ovitrelle fyldt pen til at injicere lægemidlet.
English: If you do not see a tiny drop(s) of fluid at or near the tip:
Danish: Hvis du ikke ser bittesmå dråber af væske på eller nær ved spidsen:
English: • Primary ovarian failure
Danish: • Primært ovariesvigt
English: 3.2 Prepare your needle for Injection
Danish: 3.2 Forbered kanylen til injektion
English: Safety, efficacy and pharmacokinetics of Ovitrelle in patients with renal or hepatic impairment have not been established.
Danish: Ovitrelles sikkerhed, virkning og farmakokinetik hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
English: The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
Danish: Opløsningen har en pH på 7,0 ± 0,3 og osmolalitet på 250-400 mOsm/kg.
English: • Ovarian enlargement or cyst due to reasons other than polycystic ovarian disease
Danish: • Ovarieforstørrelse eller cyste, som ikke skyldes polycystisk ovariesyndrom
English: • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and possible fluid accumulation in your stomach or chest.
Danish: • OHSS kan blive alvorlig med tydeligt forstørrede ovarier, nedsat urinproduktion, vægtstigning, vejrtrækningsbesvær og mulig væskeophobning i mave eller bryst.
English: There are no data on the excretion of choriogonadotropin alfa in milk.
Danish: Der forefindes ikke nogen data vedrørende udskillelse af choriongonadotropin i modermælk.
English: Studies on reproduction were not performed in animals.
Danish: Der er ikke udført dyreforsøg vedrørende befrugtning.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 micrograms/0.5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 250 mikrogram/0,5 ml
English: The risk of multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound).
Danish: Risikoen for flerfoldsgraviditet reduceres, hvis den sædvanlige dosis Ovitrelle anvendes og hvis du monitoreres nøje i løbet af din behandlingscyklus (f.eks. blodprøver for at teste østradiolniveauer og ultralydsscanning).
English: What do you need to know before you use Ovitrelle
Danish: Det skal du vide, før du begynder at bruge Ovitrelle
English: 5.2 Clean the skin at the injection site by wiping with an alcohol swab.
Danish: 5.2 Rens huden på indsprøjtningsstedet, ved at tørre det af med en spritserviet.
English: When undergoing Assisted Reproductive Techniques, the risk of having a multiple pregnancy is related to the number of fertilised eggs or embryos placed inside you.
Danish: Ved assisteret befrugtning hænger risikoen for at få en flerfoldsgraviditet sammen med antallet af befrugtede æg eller embryoer, der lægges tilbage.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: • Now put the pen cap back onto the pen.
Danish: • Påsæt nu hætten på pennen.
English: CAUTION: If you do not see a tiny drop(s) at or near the needle tip, you must perform the steps on the next page.
Danish: Hvis du ikke ser bittesmå dråber på eller nær ved kanylespidsen, skal du udføre trinene på den næste side.
English: The risk of OHSS is reduced if the usual dose of Ovitrelle is used, and if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound).
Danish: Risikoen for OHSS er reduceret, hvis den sædvanlige dosis af Ovitrelle anvendes, og hvis du bliver overvåget nøje under hele din behandlingscyklus (f.eks. med blodprøver for østradiol-niveauer og ultralyd).
English: See the “Instructions for use” provided in the carton.
Danish: Se den “Brugsanvisning”, som følger med kartonen.
English: Ovitrelle is not indicated during breastfeeding.
Danish: Ovitrelle er ikke indiceret under amning.
English: Manufacturer Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy
Danish: Fremstiller Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italien
English: Driving and using machines It is not expected that Ovitrelle will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Ovitrelle forventes ikke at påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: In women, chorionic gonadotropin acts as a surrogate luteinising hormone surge that triggers ovulation.
Danish: Hos kvinder har choriongonadotropin samme effekt som en pludselig luteiniserende hormon-stigning der fremkalder ovulation.
English: 3 mL cartridge (type I glass, with a bromobutyl rubber plunger stopper and an aluminium crimp cap with bromobutyl rubber) preassembled in a pre-filled pen.
Danish: 3 ml cylinderampul (type I-glas med en stempelprop af bromobutylgummi og en krympetæt aluminiumskapsel med bromobutylgummi) klargjort i en fyldt pen.
English: • Ovitrelle comes as a clear, colourless to slightly yellow liquid for injection in a pre-filled pen.
Danish: • Ovitrelle leveres som en klar, farveløs til lys gul injektionsvæske, opløsning i en fyldt pen.
English: 0.5 mL of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) - pack of 1.
Danish: 0,5 ml af opløsningen i fyldt injektionssprøjte (type 1 glas) med en stempelprop (halobutyl gummi) og stempel (plastik) og med en kanyle (rustfri stål) - pakning á 1 stk.
English: Getting your Ovitrelle pre-filled pen ready for injection 3.1 Take off the pen cap
Danish: Klargøring af din Ovitrelle fyldte pen til injektion 3.1 Tag penhætten af
English: • Your doctor will explain to you exactly when to give the injection.
Danish: • Din læge vil forklare dig, hvornår du skal tage injektionen.
English: • Each pen contains 0.5 mL of solution.
Danish: • Hver pen indeholder 0,5 ml opløsning.
English: Do not share the pen.
Danish: Lad ikke andre bruge pennen.
English: Following administration, Ovitrelle may interfere for up to ten days with the immunological determination of serum or urinary hCG, potentially leading to a false positive pregnancy test.
Danish: Ovitrelle kan påvirke den immunologiske bestemmelse af serum eller urin-baseret hCG op til ti dage efter injektion og kan medføre en falsk positiv graviditetstest.
English: See your doctor straight away if you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing.
Danish: Du skal straks kontakte din læge, hvis du får smerter nederst i maven, tager hurtigt på i vægt, føler dig utilpas eller kaster op eller har vejrtrækningsproblemer.
English: If it is not, you must adjust it
Danish: Hvis det ikke er tilfældet, skal du justere (se trin “4.
English: Other medicines and Ovitrelle Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ovitrelle Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: 5.4 Inject the dose as you were trained to do by your doctor or nurse
Danish: 5.4 Indsprøjt dosis efter instruktion fra din læge eller sygeplejerske.
English: (listed in section 6).
Danish: Ovitrelle (angivet i punkt 6).
English: • Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Danish: • Kvinder, der gennemgår superovulation med henblik på assisteret befrugtning, fx in vitro fertilisering (IVF):
English: Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours.
Danish: Efter intravenøs injektion fordeles choriongonadotropin alfa i den ekstracellulære væske; fordelinghalveringstiden er ca. 4,5 timer.
English: • Your doctor or nurse will show you how to use the Ovitrelle pre-filled syringe to inject the medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du bruger Ovitrelle fyldt injektionssprøjte til at injicere denne medicin.
English: • Your doctor will have explained exactly when to give the injection.
Danish: • Din læge har forklaret dig hvornår du skal tage injektionen.
English: • Adult women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,
Danish: • Voksne kvinder, der gennemgår superovulation med henblik på assisteret befrugtning, fx IVF (In Vitro Fertilisering): Ovitrelle gives for at fremkalde afsluttende follikelmodning og luteinisering efter follikelstimulation.
English: In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol > 3,000 pg/mL (11,000 pmol/L) and 18 or more follicles of 11 mm or more in diameter.
Danish: Ved assisteret befrugtning er risikoen for OHSS forøget ved en serumøstradiol > 3.000 pg/ml (11.000 pmol/l) og ved 18 eller flere follikler med en diameter på 11 mm eller derover.
English: Ovitrelle is indicated in the treatment of:
Danish: Ovitrelle er indiceret til:
English: • It is supplied in packs of 1 pre-filled pen and 1 injection needle.
Danish: • Det leveres i pakninger med 1 fyldt pen og 1 kanyle.
English: It is available as a single pre-filled syringe (pack of 1).
Danish: Det findes i en enkelt fyldt injektionssprøjte (pakning med 1 stk.).
English: Clear, colourless to slightly yellow solution.
Danish: Klar, farveløs til gullig opløsning.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Ovitrelle på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • if you have large ovaries or sacs of fluid within the ovaries (ovarian cysts) of unknown origin
Danish: • Hvis du har forstørrede æggestokke eller væskefyldte cyster på æggestokkene af ukendt oprindelse
English: • After the injection, dispose of the used needle safely, and discard the pen.
Danish: • Efter injektionen skal den brugte kanyle bortskaffes forsvarligt og pennen skal bortskaffes.
English: Uncommon: Depression, irritability, restlessness Nervous system disorders
Danish: Psykiske forstyrrelser Ikke almindelig: Depression, irritabilitet, rastløshed
English: Tiredness, injection site reactions.
Danish: Træthed, reaktioner på injektionsstedet.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Psychiatric disorders
Danish: Meget sjælden: Milde til alvorlige overfølsomhedsreaktioner, herunder anafylaktiske reaktioner og shock.
English: How to use your Ovitrelle pre-filled pen
Danish: Sådan skal du bruge din Ovitrelle fyldte pen
English: After opening, the medicinal product should be used immediately.
Danish: Anvendes straks efter åbning.
English: Once you have finished your injection, immediately discard the empty syringe in a sharps container.
Danish: Når injektionen er afsluttet, kasseres den tomme injektionssprøjte i en affaldsbeholder.