FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that, in accordance with EU requirements, Sabervel has been shown to have comparable quality and to be bioequivalent to Aprovel.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sabervel er af sammenlignelig kvalitet og er bioækvivalent med Aprovel.
English: Sabervel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Danish: Sabervel anvendes desuden til behandling af nyresygdom hos voksne med hypertension og type 2-diabetes.
English: Sabervel is used in adults who have essential hypertension (high blood pressure).
Danish: Sabervel anvendes til voksne med essentiel hypertension (forhøjet blodtryk).
English: The Committee recommended that Sabervel be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sabervel.
English: Because Sabervel is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Sabervel er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Sabervel been approved?
Danish: Hvorfor blev Sabervel godkendt?
English: In patients with hypertension and type 2 diabetes, Sabervel is added to other treatments for hypertension.
Danish: Til patienter med forhøjet blodtryk og type 2-diabetes anvendes Sabervel som tillægsbehandling til andre behandlinger mod forhøjet blodtryk.
English: Because Sabervel is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel.
Danish: Da Sabervel er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Aprovel.
English: What is Sabervel?
Danish: Hvad er Sabervel?
English: What is Sabervel used for?
Danish: Hvad anvendes Sabervel til?
English: How has Sabervel been studied?
Danish: Hvordan blev Sabervel undersøgt?
English: How is Sabervel used?
Danish: Hvordan anvendes Sabervel?
English: How does Sabervel work?
Danish: Hvordan virker Sabervel?
English: You have two options:
Danish: Der er to muligheder:
English: Your doctor will tell you when and how to do this.
Danish: Din læge vil oplyse dig om, hvornår og hvordan du skal gøre dette.
English:  Contact your doctor.
Danish:  Kontakt din læge.
English: Date of first authorisation: 19 March 2009 Date of latest renewal: 21 February 2014
Danish: Dato for første markedsføringstilladelse: 19. marts 2009 Dato for seneste fornyelse: 21. februar 2014
English: This may be noticed as pain in the stomach.
Danish: Dette kan opleves som smerter i maven.
English: The majority of these local reactions are mild and transient in nature.
Danish: Størstedelen af disse lokale reaktioner er milde og forbigående.
English: • if you are severely overweight.
Danish: • hvis du er svært overvægtig.
English: However, to date, no particular malformative effect has been reported.
Danish: Indtil videre er der imidlertid ikke rapporteret om nogen specielle misdannelser.
English: Fertavid is usually not effective in such cases.
Danish: Fertavid virker normalt ikke i sådanne tilfælde.
English: • are pregnant or think that you may be pregnant
Danish: • er gravid eller tror, at du kan være gravid
English: Both have an absolute bioavailability of approximately 77%.
Danish: Begge administrationsformer har en absolut biotilgængelighed på ca. 77%.
English: * Differences between the 2 groups were statistically significant (p0.05).
Danish: * Forskellene mellem de 2 grupper var statistisk signifikante (p0,05).
English: Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
Danish: Bivirkninger som kun er rapporteret én gang er listet som almindelig, fordi en enkeltstående rapport forhøjer frekvensen til over 1%.
English: Median duration of treatment (days)
Danish: Gennemsnitlig behandlingsvarighed (dage)
English: Tell your doctor immediately.
Danish: Informér straks din læge.
English: If your sperm production has not started after this period, your treatment may carry on for at least 18 months.
Danish: Hvis din sædproduktion ikke er startet efter denne periode, kan behandlingen fortsættes i mindst 18 måneder.
English: These are considered to be related to ART or subsequent pregnancy.
Danish: Disse betragtes som værende relateret til ART eller efterfølgende graviditet.
English: Your doctor will decide on your starting dose.
Danish: Din læge vil afgøre din startdosis.
English: • have been told by a doctor that pregnancy would be dangerous for you.
Danish: • hvis en læge har fortalt dig, at en graviditet vil være farlig for dig.
English: The treatment period equals the development time of sperm and the time in which improvement can be expected.
Danish: Behandlingsperioden svarer til udviklingstiden for sæd samt den tid, hvor forbedringer kan forventes.
English: • if you, or anyone in your immediate family, have ever had a thrombosis
Danish: • hvis du eller nogen i din nærmeste familie har haft en blodprop
English: Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.
Danish: På grund af risikoen for udvikling af OHSS skal patienterne følges i mindst 2 uger efter hCGadministration.
English: This dose may be adjusted during your treatment period.
Danish: Denne dosis kan justeres i løbet af behandlingen.
English: The patients should be advised of the potential risks of multiple births before starting treatment.
Danish: Patienterne bør informeres om den mulige risiko for flerfoldsfødsler før påbegyndelse af behandlingen.
English: Further details on the treatment schedule are given below.
Danish: Yderligere oplysninger om tidsplanen for behandlingen finder du nedenfor.
English: • have heavy or irregular vaginal bleeding where the cause is unknown
Danish: • du har kraftige eller uregelmæssige blødninger, hvor årsagen er ukendt
English: Treatment with Fertavid and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Danish: Behandling med Fertavid og hCG skal vare i mindst 3 til 4 måneder, før der kan forventes nogen forbedring af spermatogenesen.
English: This may be of particular relevance when switching between the pen injector and a conventional syringe within one treatment cycle.
Danish: Dette kan have særlig relevans når der skiftes mellem pennen og en almindelig sprøjte inden for samme behandlingscyklus.
English: • have adrenal glands that are not working properly (adrenocortical insufficiency)
Danish: • har binyrer, som ikke fungerer ordentligt (adrenokortikal insufficiens)
English: The risk can be reduced by careful monitoring of follicular development during treatment.
Danish: Risikoen kan reduceres ved nøje overvågning af follikeludviklingen under behandlingen.
English: Clinical experience with Fertavid is based on up to three treatment cycles in both indications.
Danish: Klinisk erfaring med Fertavid er baseret på op til 3 behandlingscykli ved begge indikationer.
English: Blood clots can lead to serious medical conditions, such as:
Danish: Blodpropper kan medføre alvorlige lidelser såsom:
English: The primary amino acid sequence is identical to that of natural human FSH.
Danish: Den primære aminosyresekvens er identisk med det naturlige humane FSH.
English: Follicles are small round sacs that contain the egg cells.
Danish: Follikler er små, runde sække, som indeholder ægcellerne.
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Fertavid induced no toxicologically significant effects.
Danish: I gentagne dosisforsøg på rotter (2 uger) og hunde (13 uger), med doser op til 100 gange større end den maksimale humane dosis, har Fertavid ikke induceret toksikologisk signifikante virkninger.
English: Clinical Efficacy and Safety
Danish: Klinisk virkning og sikkerhed
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Danish: Beskadigelse af ovarierne forårsaget af den reducerede blodforsyning kan begrænses ved tidlig diagnostisering og omgående detorsion.
English: In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary.
Danish: Kliniske studier har vist, at en vedligeholdelsesdosis varierende fra 75-375 IE i 6-12 dage er tilstrækkelig, selv om længere behandling kan være nødvendig.
English: If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Danish: Hvis patienten ikke har responderet efter denne periode, kan kombinationsbehandlingen fortsættes, idet den nuværende kliniske erfaring tyder på, at behandling i op til 18 måneder eller længere kan være nødvendig for at opnå spermatogenese.
English: • a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.
Danish: • manglende blodgennemstrømning (dyb venetrombose) som kan medføre, at du mister en arm eller et ben.
English: Single-dose administration of Fertavid to rats induced no toxicologically significant effects.
Danish: Enkeltdosis-administration af Fertavid til rotter har ikke induceret toksikologisk signifikante virkninger.
English: Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Fertavid from day to day.
Danish: Din læge vil vurdere effekten af din behandling regelmæssigt for at være i stand til vælge den rette dosis Fertavid fra dag til dag.
English: These antibiotics may cause hypersensitivity reactions in susceptible persons.
Danish: Disse antibiotika kan forårsage overfølsomhedsreaktioner hos disponerede personer.
English: Small differences in the carbohydrate chain structure are known to exist.
Danish: Der eksisterer små forskelle i strukturen af kulhydratkæderne.
English: • have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
Danish: • har haft en allergisk reaktion overfor visse antibiotika (neomycin og/eller streptomycin)
English: The use of Fertavid during pregnancy is not indicated.
Danish: Anvendelse af Fertavid er ikke indiceret under graviditet.
English: • Primary gonadal failure
Danish: • Primær gonade insufficiens
English: Fertavid contains a recombinant FSH.
Danish: Fertavid indeholder rekombinant FSH.
English: • Before starting treatment, the couple's infertility should be assessed as appropriate.
Danish: • Før behandling påbegyndes skal parrets infertilitet vurderes efter relevans.
English: A daily increase of oestradiol levels of 40-100% is considered to be optimal.
Danish: En daglig stigningsrate i estradiolniveauerne på 40-100% regnes for at være optimal.
English: Clinical use of Fertavid by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated).
Danish: Klinisk brug af Fertavid via intramuskulær eller subkutan administration kan resultere i lokale reaktioner ved injektionsstedet (3% af alle behandlede patienter).
English: Local reactions at the site of injection include induration and pain.
Danish: Lokale reaktioner på injektionsstedet inkluderer induration og smerter.
English: This increase enables therapeutic FSH concentrations to be reached.
Danish: Denne stigning medvirker til opnåelsen af terapeutiske FSH-koncentrationer.
English: Usually, 7 to 14 days of treatment are sufficient.
Danish: Normalt er 7-14 dages behandling tilstrækkeligt.
English: If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased.
Danish: Hvis antallet af responderende follikler er for højt, eller estradiolniveauerne stiger for hurtigt, dvs. mere end en daglig fordobling i 2 eller 3 på hinanden følgende dage, bør den daglige dosis sættes ned.
English: Restricted to women with ovulation induced (follitropin beta, n = 76; u-FSH, n = 42).
Danish: Begrænset til kvinder med induceret ovulation (follitropin beta, n = 76; u-FSH, n = 42).
English: Self-administration of Fertavid should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Danish: Selvadministration af Fertavid bør kun foretages af patienter, som er velmotiverede, er blevet tilstrækkeligt oplært, og som har adgang til ekspertbistand.
English: This requires ultrasound assessment of follicular development.
Danish: Dette kræver ultralydsscanning af follikeludviklingen.
English: There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins.
Danish: Der er store inter- og intraindividuelle variationer i ovariernes respons på eksogene gonadotropiner.
English: See also section 4 on possible side effects.
Danish: Se også punkt 4 ”Bivirkninger”.
English: The instructions for using the pen must be followed carefully.
Danish: Instruktionerne for brug af pennen bør følges omhyggeligt.
English: The daily dose is then maintained until pre-ovulatory conditions are reached.
Danish: Den daglige dosis vedligeholdes herefter, indtil præovulatoriske forhold nås.
English: Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given.
Danish: Specielt når der skiftes fra sprøjte til pen kan det være nødvendigt med små dosisjusteringer for at undgå at der bliver givet for stor en dosis.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsbetingelser efter første åbning af lægemidlet, se pkt.
English: Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Danish: Generaliserede allergiske reaktioner er ikke almindelige (ca. 0,2% af alle patienter, der blev behandlet med follitropin beta).
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Danish: Generel erfaring med in vitro-fertilisation har vist, at succesraten for behandlingen forbliver stabil under de 4 første forsøg og derefter falder gradvist.
English: It is possible to inject in other areas.
Danish: Det er muligt at give indsprøjtningen andre steder på kroppen.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af det biologisk aktive stof
English: The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Danish: Sprøjtens rumfang skal være tilstrækkeligt lille til, at den ordinerede dosis kan gives med rimelig nøjagtighed.
English: Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy.
Danish: Sen OHSS opstår senere end 10 dage efter hCG-administration som følge af hormonelle ændringer i forbindelse med graviditet.
English: Do not use this solution.
Danish: Anvend ikke opløsningen.
English: • Fertavid may contain traces of streptomycin and/or neomycin.
Danish: • Fertavid kan indeholde spor af streptomycin og/eller neomycin.
English: In adult females: Fertavid is indicated for the treatment of female infertility in the following clinical situations:
Danish: Voksne kvinder: Fertavid er indiceret til behandling af kvindelig infertilitet i følgende kliniske situationer:
English: To find the right dosage, your doctor will check your follicle growth by means of ultrasound scanning, and measurement of the amount of oestradiol (female sex hormone) in the blood.
Danish: For at finde den rigtige dosis vil din læge undersøge follikelvæksten ved hjælp af ultralydsscanning og måling af estradiolmængden (kvindeligt kønshormon) i blodet.
English: With the other hand, insert the needle at an angle of 90 degrees into the skin's surface, as shown in the picture (f).
Danish: Med den anden hånd stikkes nålen ind i huden i en vinkel på 90 grader, som vist på billedet (f).
English: Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Danish: Luftbobler bør fjernes fra cylinderampullen før injektion (se instruktionerne for brug af pennen).
English: Treatment with Fertavid should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling med Fertavid skal initieres under supervision af en læge, som har erfaring med behandling af fertilitetsproblemer.
English: If the needle position is correct the plunger should be quite difficult to draw back.
Danish: Hvis nålen er placeret korrekt, vil det være ret besværligt at trække stemplet tilbage.
English: If you are troubled by stomach pains, tell your doctor immediately.
Danish: Hvis du generes af mavesmerter, skal du straks kontakte din læge.
English: Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Danish: Flerfoldsgraviditet medfører en helbredsrisiko for både mor og spædbørn omkring fødselstidspunktet.
English: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss The Netherlands
Danish: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss Holland
English: It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
Danish: Det skal dog bemærkes, at graviditet i sig selv medfører en øget risiko for trombose.
English: Median total dose (IU)
Danish: Gennemsnitlig total-dosis (IE)
English: These side effects are not considered to be related to the use of Fertavid, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Danish: Disse bivirkninger anses ikke for at være relateret til behandlingen med Fertavid, men til den kunstige befrugtning (assisteret reproduktionsbehandlingsteknologi - ART) eller den efterfølgende graviditet.
English: FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
Danish: FSH tilhører gruppen af gonadotropiner og spiller en vigtig rolle for frugtbarhed og forplantning hos mennesker.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Fertavid.
Danish: Sygdomme, som kontraindicerer graviditet, skal også evalueres, før behandling med Fertavid påbegyndes.
English: The active substance follitropin beta.
Danish: Aktivt stof: follitropin beta.
English: To assess the response, semen analysis is recommended 4 to 6 months after the beginning of treatment.
Danish: For at vurdere responset, anbefales det at foretage sædanalyse 4 til 6 måneder efter behandlingsstart.
English: Treatment of females:
Danish: Behandling af kvinder:
English: Children There is no relevant use of Fertavid in children.
Danish: Børn Det er ikke relevant at anvende Fertavid hos børn.
English: Subcutaneous (SC) use
Danish: Subkutan (s.c.) anvendelse
English: Please discuss this with your doctor, before starting treatment, especially:
Danish: Du skal tale med din læge om dette, før du begynder på behandlingen, specielt:
English: Such patients are unresponsive to Fertavid/hCG therapy.
Danish: Sådanne patienter reagerer ikke på Fertavid/hCG behandling.
English: Vascular Complications
Danish: Vaskulære komplikationer
English: After intramuscular administration of Fertavid, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Danish: Efter intramuskulær administration af Fertavid er de maksimale FSHkoncentrationer højere og opnås tidligere hos mænd end hos kvinder.
English: Infertile women undergoing ART have an increased incidence of ectopic pregnancies.
Danish: Infertile kvinder, der gennemgår ART, har en øget hyppighed af ektopisk graviditet.
English: There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Fertavid.
Danish: Der er ingen signifikante farmakokinetiske forskelle mellem intramuskulær og subkutan administration af Fertavid.
English: • Women who are not ovulating A starting dose is set by your doctor.
Danish: • Kvinder som ikke har ægløsning Din læge fastsætter en startdosis.
English: This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries are overly stimulated and the growing follicles become larger than normal.
Danish: Dette er meget vigtigt, da en for høj dosis FSH kan medføre sjældne, men alvorlige komplikationer, hvor æggestokkene bliver overstimuleret og de voksende follikler bliver større end normalt.
English: The separate instructions for using the pen must be followed carefully.
Danish: De særlige instruktioner for brugen af pennen skal følges nøje.
English: There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.
Danish: Der er ingen tilgængelig information fra kliniske studier eller dyreforsøg om udskillelsen af follitropin beta i mælk.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. injektion, d.v.s. den er i det væsentlige ”natriumfri”.
English: Any unused solution should be discarded.
Danish: Ubrugt opløsning bør destrueres.
English: Treatment with Fertavid is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Danish: Behandling med Fertavid efterfølges sædvanligvis af administration af hCG for at inducere den sidste fase af follikelmodningen, genoptagelse af meiosen og follikelruptur.
English: Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
Danish: Spontan abort Abortraten hos kvinder i assisteret reproduktionsbehandling er højere end i den normale population.
English: A sequential treatment scheme is recommended starting with daily administration of 50 IU Fertavid.
Danish: Generelt anbefales det at bruge et "step-up"-behandlingsskema startende med en daglig administration på 50 IE Fertavid.
English: Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days after the last injection has been given.
Danish: Du skal straks kontakte din læge, hvis du får mavesmerter, også hvis smerterne optræder nogle dage efter, du har fået den sidste injektion.
English: If you:
Danish: Hvis:
English: Due to the relatively long elimination halflife, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Danish: På grund af den relativt lange eliminationshalveringstid vil gentagen administration af den samme dosis medføre FSHplasmakoncentrationer, som er ca. 1,5-2,5 gange højere end efter administration af en enkelt dosis.
English: Ovarian response is monitored by ultrasound assessment.
Danish: Ovariernes respons monitoreres ved hjælp af ultralydsscanning.
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Danish: Forekomsten af medfødte misdannelser efter anvendelse af ART kan være en smule højere end efter spontan undfangelse.
English: Discard used needles immediately after injection.
Danish: Kassér brugte nåle straks efter injektion.
English: • are allergic to follitropin beta or any of the other ingredients of Fertavid (listed in section 6)
Danish: • du er allergisk over for follitropin beta eller et af de øvrige indholdsstoffer i Fertavid (angivet i punkt 6)
English: Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before you proceed.
Danish: Rens ca. 5 cm rundt om indsprøjtningsstedet og lad desinfektionsmidlet tørre i mindst 1 minut, før De går videre.