FrancophonIA/ELRC3.0 huggingface dataset:
English: • According to your response, your doctor may decide to add every day a dose of a licensed follitropin alfa preparation to your Pergoveris injection.
Danish: • Afhængig af dit respons kan lægen beslutte at tilføje en dosis af et godkendt follitropin alfa præparat til din Pergoveris injektion.
English: • Attach the needle for preparation to the empty syringe for injection.
Danish: • Sæt nålen til tilberedning på den tomme sprøjte til injektion.
English: Setting the dose prescribed by your doctor 6.1.
Danish: Indstilling af dosis ordineret af lægen 6.1.
English: Pregnancy and breast-feeding Do not use Pergoveris if you are pregnant or breast-feeding.
Danish: Graviditet og amning Brug ikke Pergoveris, hvis du er gravid eller ammer.
English: • If needed, turn the dose setting knob backward to correct the dose.
Danish: • Hvis det er nødvendigt, drejes dosisindstillingsknappen tilbage for at korrigere dosis.
English: Elimination Total clearance is 0.6 L/h and one-eighth of the follitropin alfa dose is excreted in the urine.
Danish: Elimination Den totale clearance er 0,6 l/t og en ottendedel af follitropin alfa-dosen udskilles i urinen.
English: • Your doctor/pharmacist will tell you how many pens of Pergoveris you need to complete your treatment.
Danish: • Lægen/apotekspersonalet vil fortælle dig, hvor mange penne med Pergoveris du skal bruge for at gennemføre din behandling.
English: Remove the needle immediately after each injection.
Danish: Fjern kanylen umiddelbart efter hver injektion.
English: Prepare your needle.
Danish: Forbered kanylen.
English: In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
Danish: I kliniske forsøg er virkningen af kombinationen af follitropin alfa og lutropin alfa blevet demonstreret hos kvinder med hypogonadotrop hypogonadisme.
English: Pergoveris treatment seldom causes severe OHSS.
Danish: Pergoveris-behandling fører sjældent til alvorlig
English: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours.
Danish: Efter intravenøs injektion bliver lutropin alfa hurtigt fordelt med en initial halveringstid på cirka en time og elimineret fra kroppen med en terminal halveringstid på cirka 10-12 timer.
English: • if you have cancer in your ovaries, womb or breasts
Danish: • hvis du har kræft i æggestok, livmoder eller bryst
English: • Serious blood clotting problems (thromboembolic events) usually with severe OHSS are found very rarely.
Danish: • Alvorlige komplikationer med blodpropper (tromboemboliske hændelser) sædvanligvis ved alvorlig OHSS kan forekomme meget sjældent.
English: Pergoveris is indicated for use in infertility (see section 4.1).
Danish: Pergoveris er indiceret til brug ved infertilitet (se pkt.
English: • Remove the peel-off seal (Fig. 4).
Danish: • Fjern den aftagelige forseglingsflig (figur 4).
English: Once you have finished your injection, immediately discard all needles and empty vials in your sharps container.
Danish: Straks efter, at du har afsluttet injektionen, kasseres alle nålene og de tomme hætteglas i beholderen til skarpt affald.
English: Pergoveris contains potent gonadotrophic substances 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: Pergoveris indeholder potente gonadotropiner, som kan fremkalde milde til alvorlige bivirkninger, og det bør derfor kun bruges af læger, som er specialiserede i infertilitetsbehandling.
English: If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing.
Danish: Hvis der opstår alvorlig OHSS, skal evt. igangværende gonadotropinbehandling stoppes.
English: • if you have large ovaries or sacs of fluid within your ovaries (ovarian cysts) of unknown origin
Danish: • hvis du har store æggestokke eller væskefyldte sække i æggestokkene (ovariecyster) af ukendt oprindelse
English: Marketing Authorisation Holder Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Danish: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, Holland
English: After the injection, dispose of the used needle safely.
Danish: Efter injektionen bortskaffes den brugte kanyle på sikker vis.
English: Do not use Pergoveris with other medicines in the same injection, except for follitropin alfa, if prescribed by your doctor.
Danish: Brug ikke Pergoveris sammen med anden medicin i samme injektion, bortset fra follitropin alfa, hvis din læge har ordineret det.
English: Driving and using machines It is not expected that this medicine will affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det forventes ikke, at denne medicin vil påvirke din evne til at føre motorkøretøj.
English: Warning: Do not recap the needle with the green inner shield, as it can lead to needle stick.
Danish: Advarsel: Sæt ikke den grønne indre beskyttelse på kanylen, da det kan forårsage stikskader.
English: • local reactions at the injection site such as pain, itching, bruising, swelling or irritation.
Danish: • lokale reaktioner på injektionsstedet såsom smerte, kløe, blå mærker, hævelse eller irritation.
English: This increases your risk of developing ovarian hyperstimulation syndrome (OHSS).
Danish: Dette forøger din risiko for at udvikle ovarielt hyperstimulationssyndrom (OHSS).
English: There is no indication for the use of Pergoveris during pregnancy.
Danish: Der er ingen indikation for Pergoveris under graviditet.
English: By replacing the missing hormones, Pergoveris allows women with low levels of FSH and LH to develop a follicle.
Danish: Gennem erstatning af de manglende hormoner gør Pergoveris det muligt for kvinder med lave FSHog LH-niveauer at udvikle en follikel.
English: Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
Danish: Flerfoldsgraviditet, især i mangefold, medfører en øget risiko for skadeligt udfald for moder og foster.
English: Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Danish: Før behandlingen begynder, bør det vurderes, om parrets infertilitet er egnet til behandling, og mulige kontraindikationer for graviditet vurderes.
English: Solvent: clear colourless solution.
Danish: Solvens: Klar farveløs væske.
English: • The solvent is a clear colourless liquid in a glass vial containing1 mL of water for injections.
Danish: • Solvensen er en klar farveløs væske i et hætteglas indeholdende 1 ml vand til injektionsvæsker.
English: • Then withdraw the needle and clean the skin with a new alcohol swab using a circular motion.
Danish: • Træk dernæst nålen ud og rens huden med et ny spritserviet med cirkulerende bevægelser.
English: Caution: Do not release the dose knob until you remove the needle from the skin.
Danish: Forsigtig: Du må ikke slippe dosisknappen, før du har trukket kanylen ud af huden.
English: Getting your Pergoveris pre-filled pen ready for injection 5.1.
Danish: Klargøring af din Pergoveris fyldte pen til injektion 5.1.
English: (Getting your Pergoveris pre-filled pen ready for injection) with a second pen.
Danish: (Klargøring af din Pergoveris fyldte pen til injektion) med en ny pen.
English: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare:
Danish: Tromboemboli, normalt forbundet med alvorlig OHSS Luftveje, thorax og mediastinum Meget sjælden:
English: There is no relevant indication for the use of Pergoveris in the elderly population.
Danish: Det er ikke relevant at anvende Pergoveris hos den ældre population.
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 alvorlig OHSS blive kompliceret af ovarietorsion eller tromboemboliske hændelser, som f.eks. lungeemboli, iskæmisk apopleksi eller myokardieinfarkt.
English: a. Dial your prescribed dose.
Danish: a. Indstille din ordinerede dosis.
English: In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
Danish: Ved stimulering af follikeludviklingen hos anovulatoriske kvinder med LH- og FSH-mangel er den primære effekt, der opnås ved behandling med lutropin alfa, en øget østradiolsekretion fra folliklerne, hvis vækst stimuleres af FSH.
English: Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling med Pergoveris må kun påbegyndes under opsyn af en speciallæge med erfaring inden for fertilitetsbehandling.
English: In women whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Danish: Hos kvinder, hvis endogene gonadotropin sekretion er undertrykt, har det ikke desto mindre vist sig, at follitropin alfa effektivt stimulerer follikeludviklingen og steroidogenesen på trods af umålelige LH-værdier.
English: • Remove the protective cap from the vial filled with water (solvent vial).
Danish: • Fjern beskyttelseslåget fra hætteglasset fyldt med vand (solvens hætteglas).
English: Pack sizes of 1, 3 and 10 vials with the corresponding number of solvent's vial (1, 3 and 10 vials).
Danish: Pakninger a 1, 3 eller 10 hætteglas med et tilsvarende antal solvenshætteglas (1, 3 og 10).
English: When an optimal response is obtained, a single injection of 250 micrograms of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Pergoveris injection.
Danish: Når optimalt respons er opnået, gives én injektion med 250 mikrogram r-hCG eller 5.000-10.000 IE hCG inden for 24-48 timer efter sidste injektion af Pergoveris.
English: • Your doctor or nurse will show you how to use the Pergoveris pre-filled pen to inject the medicine.
Danish: • Din læge eller sygeplejerske vil vise dig, hvordan du bruger Pergoveris fyldt pen til at indsprøjte medicinen.
English: • Remove the protective cap from the vial filled with Pergoveris powder.
Danish: • Fjern beskyttelseslåget fra hætteglasset fyldt med Pergoveris pulver.
English: • The numbers displayed in the Dose Feedback Window help you to:
Danish: • Tallene på skærmen med dosisfeedback hjælper med at:
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Danish: Bivirkninger opstilles herunder efter systemorganklasse og hyppighed i henhold til MedDRA.
English: In one clinical study of women with hypogonadotrophic hypogonadism and an endogenous serum LH concentration below 1.2 IU/L the appropriate dose of r-hLH was investigated.
Danish: I et klinisk forsøg med kvinder med hypogonadotrop hypogonadisme og endogen serum-LHkoncentration under 1,2 IE/l blev den passende dosis af r-hLH undersøgt.
English: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Danish: • overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: • The Pergoveris pre-filled pen is for subcutaneous injection only.
Danish: • Pergoveris fyldt pen er kun til subkutan injektion.
English: Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established.
Danish: Dette lægemiddels sikkerhed, virkning og farmakokinetik hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
English: Pergoveris may be mixed with follitropin alfa and co-administered as a single injection.
Danish: Pergoveris kan blandes med follitropin alfa og indgives som én injektion.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Pergoveris
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Pergoveris
English: Patients undergoing stimulation of follicular growth are at an increased risk of developing hyperstimulation in view of possible excessive oestrogen response and multiple follicular development.
Danish: For patienter, som gennemgår stimulation af follikeludvikling, øges risikoen for udvikling af hyperstimulation forårsaget af forhøjet østrogenrespons og multipel follikeludvikling.
English: • fibroid tumours of the uterus incompatible with pregnancy
Danish: • fibromer i livmoderen, der er uforenelige med graviditet
English: • 1 fine bore needle for injection under the skin
Danish: • 1 fin nål til injektion under huden
English: Prescribed Dose
Danish: Ordineret Dosis
English: • Pergoveris is supplied in packs of 1, 3 and 10 vials of powder with the corresponding number of solvent's vials (1, 3 and 10 vials).
Danish: • Pergoveris leveres i pakninger indeholdende 1, 3 og 10 hætteglas med pulver sammen med et tilsvarende antal solvens hætteglas (1, 3 og 10).
English: *recombinant human follitropin alfa and recombinant human lutropin alfa are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Danish: *rekombinant humant follitropin alfa og rekombinant humant lutropin alfa er fremstillet i ovarieceller fra kinesisk hamster (CHO) ved hjælp rekombinant dna-teknologi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SOLVENS HÆTTEGLAS
English: • Screw the threaded tip of the Pergoveris pre-filled pen into the outer needle cap until you feel a light resistance.
Danish: • Skru gevindspidsen på Pergoveris fyldt pen i den ydre kanylehætte, indtil du mærker en let modstand.
English: Pergoveris must be reconstituted with the solvent before use by gentle swirling.
Danish: Pergoveris skal opløses i solvensen før brug ved hjælp af lette cirkulære bevægelser.
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.
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 pkt.
English: The patient should be hospitalised and specific therapy for OHSS started.
Danish: Patienten bør indlægges på hospital og behandles for OHSS.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Danish: Efter intravenøs administration fordeles follitropin alfa til extracellulærvæsken med en initial halveringstid på ca. 2 timer og elimineres med en terminal halveringstid på ca. 1 døgn.
English: A recommended regimen commences with one vial of Pergoveris daily.
Danish: Et anbefalet behandlingsregime starter med et hætteglas Pergoveris dagligt.
English: Talk to your doctor before using Pergoveris if you or a member of your family have ever had blood clots in the leg or in the lung, or a heart attack or stroke.
Danish: Problemer med blodpropper (tromboemboliske hændelser) Fortæl det til din læge, inden du bruger Pergoveris, hvis du (eller et familiemedlem) tidligere eller for nylig har haft blodpropper i benene eller i lungerne, eller et hjerteanfald eller et slagtilfælde.
English: When risk of multiple pregnancies is assumed, treatment discontinuation should be considered.
Danish: Når der vurderes at være risiko for flerfoldsgraviditet, bør det overvejes at stoppe behandlingen.
English: • Turn the vial upside down and gently draw up all the water (solvent).
Danish: • Vend hætteglasset på hovedet og træk forsigtigt alt vand op (solvens).
English: The reconstituted solution should not be administered if it contains particles or is not clear.
Danish: Opløsningen må ikke injiceres, hvis den indeholder partikler eller er uklar.
English: • 1 vial containing Pergoveris powder • 1 vial containing water for injections (solvent)
Danish: • 1 hætteglas med Pergoveris pulver • 1 hætteglas med vand til injektioner (solvens)
English: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Danish: Hos kvinder med LH- og FSH-mangel (hypogonadotrof hypogonadisme) er formålet med Pergoverisbehandlingen at udvikle en enkelt moden Graafsk follikel, hvorfra oocyten kan frigøres efter injektion med humant choriongonadotropin (hCG).
English: Pergoveris is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Danish: Pergoveris er et præparat af rekombinant humant follikelstimulerende hormon (follitropin alfa, r-hFSH) og rekombinant humant luteiniserende hormon (lutropin alfa, r-hLH) produceret i genetisk modificerede ovarieceller fra kinesisk hamster (CHO-celler) ved hjælp af rekombinant dna-teknologi.
English: Severe OHSS is uncommon (see section 4.4).
Danish: Alvorlig OHSS er ikke almindelig (se pkt.
English: • Record your prescribed dose (column 5).
Danish: • Registrér din ordinerede dosis (søjle 5).
English: Therefore, administration of less than one vial of Pergoveris daily may provide too little LH-activity to ensure adequate follicular development.
Danish: Derfor kan brug af mindre end ét hætteglas Pergoveris dagligt give for lav LH-aktivitet til at sikre tilstrækkelig follikulær udvikling.
English: If less than one vial daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1).
Danish: Hvis der anvendes mindre end ét hætteglas dagligt, kan follikel-responset blive utilfredstillende, da mængden af lutropin alfa kan være utilstrækkelig (se pkt.
English: When a risk of OHSS is assumed, treatment discontinuation should be considered.
Danish: Når der vurderes at være risiko for OHSS, bør det overvejes at stoppe behandlingen.
English: Gonadotrophin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities.
Danish: Behandling med gonadotropiner er tidskrævende for lægen og øvrigt sundhedspersonale og kræver desuden tilgang til særligt monitoreringsudstyr.
English: Tiny amounts of concentrated phosphoric acid and sodium hydroxide are added to keep acidity levels (pH levels) normal.
Danish: Der er tilsat minimale mængder koncentreret phosphorsyre og natriumhydroxid for at holde surhedsgraden (pH-niveauet) normalt.
English: Therefore, administration of Pergoveris containing less than 75 IU r-hLH daily may provide too little LH-activity to ensure adequate follicular development.
Danish: Derfor kan administration af Pergoveris, der indeholder mindre end 75 IE r-hLH dagligt give for lav LH-aktivitet til at sikre tilstrækkelig follikulær udvikling.
English: Do not use Pergoveris
Danish: Brug ikke Pergoveris:
English: Women who have ever had blocked or damaged fallopian tubes (tubal disease) are at risk of pregnancy where the embryo is implanted outside the womb (ectopic pregnancy).
Danish: Kvinder, der har haft blokerede eller beskadigede æggeledere (sygdom i æggelederne) har risiko for graviditet uden for livmoderen (ektopisk graviditet).
English: Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4).
Danish: Tromboemboli kan forekomme meget sjældent, sædvanligvis i forbindelse med alvorlig OHSS (se pkt.
English: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Forekomsten af medfødte misdannelser efter ART kan være let forøget sammenlignet med spontan konception.
English: If less than the recommended dose daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1).
Danish: Hvis der anvendes mindre end den anbefalede dosis Pergoveris dagligt, kan follikelresponset blive utilfredsstillende, da mængden af lutropin alfa kan være utilstrækkeligt (se pkt.
English: A dose of 25 IU r-hLH daily (in combination with 150 IU r-hFSH) resulted in insufficient follicular development.
Danish: En dosis på 25 IE r-hLH dagligt (i kombination med 150 IE r-hFSH) resulterede i utilstrækkelig follikulær udvikling.
English: • When the needle is out of the skin, release the dose setting knob.
Danish: • Når kanylen er trukket ud af huden, slippes dosisindstillingsknappen.
English: The steady state volume of distribution is around 10-14 L. Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Danish: Fordelingssvolumenet er ved steady-state cirka 10-14 l. Målt ved hjælp af AUC udviser lutropin alfa lineær farmakokinetik, som er direkte proportional med den injicerede dosis.
English: • Pick up your syringe and slowly inject the contents of the syringe into the vial of powder.
Danish: • Tag sprøjten op og sprøjt forsigtig indholdet af sprøjten i hætteglasset med pulver.
English: • Turn the dose setting knob forward to dial up according to the dose that was prescribed by your doctor.
Danish: • Drej dosisindstillingsknappen fremad for at opjustere til den dosis, som lægen har ordineret.
English: • Insert the needle into the vial, push the plunger to expel the air.
Danish: • Indfør nålen i hætteglasset, skub stemplet for at presse luften ud.
English: Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Pergoveris indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisnng.
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress, and thromboembolic events.
Danish: En klinisk undersøgelse kan påvise: Hypovolæmi, hæmokoncentration, elektrolytubalance, ascites, hæmoperitoneum, pleuraekssudat, hydrothorax eller akut pulmonær distress og tromboemboliske hændelser.
English: Do not use this medicine if any of the above apply to you.
Danish: Brug ikke Pergoveris, hvis noget af ovenstående gælder for dig.
English: • Needles (included in the pack)
Danish: • Kanyler (medfølger i pakningen)
English: Other medicines and Pergoveris Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Pergoveris Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Lower abdominal pain together with nausea or vomiting.
Danish: • Smerter i nederste del af maven i kombination med kvalme eller opkastning.
English: You can use Pergoveris with a licensed follitropin alfa preparation as separate injections, if prescribed by your doctor.
Danish: Du kan bruge Pergoveris sammen med et godkendt follitropin alfa-præparat som separate injektioner, hvis din læge har ordineret det.
English: The lutropin alfa pharmacokinetics following single and repeated administration of lutropin alfa are comparable and the accumulation ratio of lutropin alfa is minimal.
Danish: Lutropin alfas farmakokinetik er sammenlignelig efter enkel og gentagen injektion af lutropin alfa, og akkumulationsratio for lutropin alfa er minimal.