FrancophonIA/ELRC3.0 huggingface dataset:
English: When ProteqFlu is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains as ‘foreign' and makes antibodies against them.
Danish: Når hestene vaccineres med ProteqFlu, opfatter immunsystemet disse specifikke proteiner fra stammerne fra hesteinfluenza som "fremmede" og producerer antistoffer mod dem.
English: ProteqFlu is a vaccine for use in horses.
Danish: ProteqFlu er en vaccine til heste.
English: The studies showed that ProteqFlu was effective in reducing clinical signs and virus excretion after infection with equine influenza, 14 days after primary vaccination.
Danish: Undersøgelserne viser, at ProteqFlu er effektiv til at nedsætte kliniske symptomer og virusudskillelse efter infektion med hesteinfluenza, 14 dage efter den første vaccination.
English: ProteqFlu is available as a suspension for injection.
Danish: ProteqFlu fås som en suspension til injektion.
English: Why has ProteqFlu been approved?
Danish: Hvorfor blev ProteqFlu godkendt?
English: What is the risk associated with ProteqFlu?
Danish: Hvilken risiko er der forbundet med ProteqFlu?
English: This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations.
Danish: Basisvaccinationen bør følges op af en revaccination 5 måneder senere og derefter af en boostervaccination én gang om året.
English: The current formulation of ProteqFlu produced similar antibody responses against the two flu strains included in the vaccine to those seen in the main studies.
Danish: Den aktuelle formulering af ProteqFlu dannede den samme mængde antistoffer mod de to influenzastrenge, der indgår i vaccinen, som dem, der sås i hovedundersøgelserne.
English: This will help to protect against equine influenza.
Danish: Dette er med til at beskytte mod hesteinfluenza.
English: ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza.
Danish: ProteqFlu anvendes til vaccination af heste, fra de er 4 måneder, mod hesteinfluenza.
English: Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Danish: De fleste undersøgelser blev foretaget med ProteqFlu-Te, en vaccine, der beskytter mod to hesteinfluenzastammer og mod stivkrampe.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively.
Danish: Den indeholder dele af to hesteinfluenzastammer, der er indsat i hver sin vektorvirus (bærervirus), som hedder canarypox.
English: What is ProteqFlu?
Danish: Hvad er ProteqFlu?
English: The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Danish: Vaccinen nedsætter de kliniske symptomer på hesteinfluenza og virusudskillelsen efter infektion.
English: The measure of effectiveness in all studies was antibody levels against the two influenza vaccine strains.
Danish: Behandlingens virkning blev i alle undersøgelserne hovedsagelig bedømt på mængden af beskyttende antistoffer mod de to influenzavaccinestammer, som blev dannet.
English: What is ProteqFlu used for?
Danish: Hvad anvendes ProteqFlu til?
English: How has ProteqFlu been studied?
Danish: Hvordan blev ProteqFlu undersøgt?
English: A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.
Danish: Der kan forekomme en kortvarig hævelse på injektionsstedet (maks.
English: What benefit has ProteqFlu shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ProteqFlu?
English: How does ProteqFlu work?
Danish: Hvordan virker ProteqFlu?
English: There are two options:
Danish: Der er to muligheder:
English: See Table 1 below.
Danish: Se tabel 1 nedenfor.
English: Date of first authorisation: 25 January 2010 Date of latest renewal: 22 August 2014
Danish: Dato for første markedsføringstilladelse: 25. januar 2010 Dato for seneste fornyelse: 22. august 2014
English: (See also section 4.)
Danish: (Se også punkt 4.)
English: The absolute bioavailability is 58% (48-70%
Danish: Den absolutte biotilgængelighed er 58% (48-70%
English: This may be continued for a few days until enough follicles of adequate size are present.
Danish: Dette kan fortsættes i få dage, indtil der er nok follikler af passende størrelse.
English: The eggs are collected from the ovary 34-36 hours later.
Danish: Æggene udtages fra æggestokkene 34-36 timer senere.
English: - Wash your hands with soap and water and dry them before you use Elonva.
Danish: - Vask dine hænder med vand og sæbe, og tør dem, før du tager Elonva.
English: Difference [95% CI]
Danish: Forskel [95% CI]
English: 1) and is reached 44 hours (35-57 hours
Danish: 1), og den nås 44 timer (35-57 timer
English: In case of a positive pregnancy test, contact your doctor.
Danish: I tilfælde af en positiv graviditetstest skal du kontakte lægen.
English: See below for further explanation.
Danish: Se nedenfor for yderligere information.
English: However, the differences were within the predefined equivalence (ENGAGE and ENSURE) or non-inferiority (PURSUE) margins.
Danish: Forskellene lå dog inden for de prædefinerede ækvivalensmarginer (ENGAGE og ENSURE) eller non-inferioritetsmarginer (PURSUE).
English: Your doctor will advise you at what time you can start performing pregnancy tests.
Danish: Din læge vil råde dig til, hvornår du kan starte med at tage graviditetstests.
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 at udvikle OHSS skal patienterne følges i mindst 2 uger efter hCG administration.
English: *Adverse reactions were identified through post-marketing surveillance.
Danish: *Bivirkningerne blev identificeret under overvågning efter markedsføring.
English: Make a note of when you start storing the product out of the refrigerator, and use it within one month of that date.
Danish: Notér hvornår du har taget produktet ud af køleskabet og brug det indenfor en måned.
English: Multiple pregnancies carry an increased health risk for both the mother and her babies.
Danish: Flerfoldsgraviditet medfører en højere sundhedsrisiko for både moderen og hendes børn.
English: These are considered to be related to ART or subsequent pregnancy.
Danish: Dette menes at være relateret til ART eller efterfølgende graviditet.
English: The chance of having a side effect is described by the following categories:
Danish: Risikoen for bivirkninger er inddelt i følgende kategorier:
English: No interaction studies with Elonva and other medicines have been performed.
Danish: Der er ikke udført interaktionsstudier med Elonva og andre lægemidler.
English: The steady state volume of distribution is 9.2 L (6.5-13.1 L
Danish: Fordelingsvolumen ved steady state er 9,2 l (6,5-13,1 l
English: This trial also provided safety data on the infants born from cryopreserved embryos.
Danish: Dette studie gav også sikkerhedsdata for de spædbørn, som blev født fra kryopræserverede embryoner.
English: Infertility evaluation before starting treatment
Danish: Vurdering af infertilitet før påbegyndelse af behandling
English: In general, adequate follicular development is achieved on average by the ninth day of treatment (range 6 to 18 days).
Danish: Der opnås almindeligvis tilstrækkelig follikeludvikling på omkring 9. behandlingsdag (mellem 6 og 18 dage).
English: Do not use Elonva if the solution is not clear.
Danish: Brug ikke Elonva, hvis opløsningen er uklar.
English: Not known (cannot be estimated from available data) - Allergic reactions (hypersensitivity reactions, both local and generalised, including rash).
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - Allergiske reaktioner (overfølsomhedsreaktioner, både lokalt og generaliseret, inklusive udslæt).
English: Therefore, the use of Elonva in these women is not recommended.
Danish: Derfor anbefales brug af Elonva ikke til disse kvinder.
English: Per embryo transfer.
Danish: Pr. oplægning af embryoner.
English: Stimulation day 5 or 6:
Danish: Stimulationsdag 5 eller 6:
English: Both embryotoxicity and teratogenicity are considered a consequence of the superovulatory state of the animal not able to support a number of embryos above a physiological ceiling.
Danish: Både embryotoksicitet og teratogenicitet menes at være konsekvenser af superovulationstilstanden hos dyret, som ikke kan støtte et antal embryoner over et fysiologisk loft.
English: The chance of having this complication can be reduced by carefully monitoring the number of maturing follicles.
Danish: Risikoen for at få denne komplikation kan reduceres ved omhyggelig overvågning af antallet af follikler.
English: Your doctor may also check blood hormone levels.
Danish: Din læge kan også kontrollere niveauet af hormoner i blodet.
English: Therefore, close supervision by your doctor is very important.
Danish: Derfor er det meget vigtigt, at din læge følger dig nøje.
English: Storage by the patient
Danish: Opbevaring hos patienten
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: Results of a small uncontrolled study suggest a higher ovarian response than in combination with a GnRH antagonist.
Danish: Resultater fra en lille ukontrolleret undersøgelse tyder på en højere ovariel respons end i kombination med en GnRH-antagonist.
English: The injection may be given by a healthcare professional (for example a nurse), your partner or yourself, if carefully instructed by your doctor.
Danish: Indsprøjtningen kan foretages af en professionel (f.eks. en sygeplejerske), din partner eller dig selv, hvis du har fået anvisninger fra lægen.
English: Less than 50 kg
Danish: Mindre end 50 kg
English: Do not inject Elonva into a muscle.
Danish: Indsprøjt ikke Elonva i en muskel.
English: Corifollitropin alfa has an elimination half-life of 70 hours (59-82 hours
Danish: Corifollitropin alfa har en eliminationshalveringstid på 70 timer (59-82 timer
English: If OHSS develops, standard and appropriate management of OHSS should be implemented and followed.
Danish: Hvis der udvikles OHSS, bør relevant standardbehandling af OHSS implementeres og følges.
English: Self administration of Elonva should only be performed by women who are well-motivated, adequately trained and with access to expert advice.
Danish: Selv-administration af Elonva bør kun fortages af kvinder, der er motiverede, tilstrækkeligt trænede og som har adgang til eksperthjælp.
English: These side effects are not considered to be related to the use of Elonva, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Danish: Disse bivirkninger betragtes ikke som værende relateret til brugen af Elonva, men relateret til assisteret reproduktionsbehandlingsteknologi (ART) eller efterfølgende graviditet.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Treatment with the GnRH-antagonist usually starts 5 to 6 days after the injection of Elonva.
Danish: Behandling med GnRH-antagonisten starter sædvanligvis 5-6 dage efter indsprøjtningen af Elonva.
English: - Clean about 5 cm around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Danish: - Rengør ca. 5 cm rundt om det sted, hvor nålen skal stikkes ind, og lad desinfektionsmidlet tørre i mindst 1 minut, før du fortsætter.
English:  Ovarian cysts or enlarged ovaries.
Danish: • Ovariecyster eller forstørrede ovarier.
English: The woman and her partner should be advised of the potential risks for the mother (pregnancy and delivery complications) and the neonate (low birth weight) before starting treatment.
Danish: Kvinden og hendes partner skal oplyses om den potentielle risiko for moderen (komplikationer under graviditet og fødsel) og den nyfødte (lav fødselsvægt), før behandlingen igangsættes.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA09
Danish: Farmakoterapeutisk klassifikation: kønshormoner og modulatorer af genitalsystemet, gonadotropiner ATC-kode: G03GA09
English: Hypersensitivity reactions, both local and generalised, including rash*
Danish: Overfølsomhedsreaktioner, både lokalt og generaliseret inklusive udslæt*
English: If you forgot to inject Elonva on the day you should have, contact your doctor immediately.
Danish: Hvis du har glemt at tage Elonva den dag du burde, skal du straks kontakte lægen.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstillere af det biologisk aktive stof
English: Before starting treatment, the couple's infertility should be assessed as appropriate.
Danish: Før behandling startes, skal parrets infertilitet vurderes på passende vis.
English: Do not inject Elonva without talking with your doctor.
Danish: Du må ikke indsprøjte Elonva uden at have talt med din læge.
English: In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Treatment with a GnRH antagonist should be started on stimulation day 5 or day 6 depending on the ovarian response, i.e. the number and size of growing follicles.
Danish: Behandling med en GnRH-antagonist bør startes på stimulationsdag 5 eller 6 afhængigt af det ovarielle respons, d.v.s. antal og størrelse af voksende follikler.
English: Alanine aminotransferase increased, aspartate aminotransferase increased
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase
English: OHSS may be caused by administration of hCG and by pregnancy (endogenous hCG).
Danish: OHSS kan forårsages af administration af hCG og af graviditet (endogent hCG).
English: No clinical studies have been performed in patients with renal insufficiency.
Danish: Der er ikke udført kliniske studier hos patienter med nyreinsufficiens.
English: In these clinical trials, the safety profile of a single injection with Elonva was comparable to daily injections with recFSH.
Danish: I disse kliniske studier var sikkerhedsprofilen for en enkelt injektion med Elonva sammenlignelig med daglige injektioner med recFSH.
English: Dosing during the stimulation cycle
Danish: Dosering i stimulationscyklussen
English: No studies on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: Additional injections of Elonva should not be given within the same treatment cycle.
Danish: Flere injektioner med Elonva må ikke gives inden for den samme behandlingscyklus.
English: This can be checked by ultrasound examination.
Danish: Dette kan konstateres ved ultralydsscanning.
English: Exposure to corifollitropin alfa increases proportionally with dose within the range of 60 micrograms to 240 micrograms.
Danish: Eksponeringen for corifollitropin alfa øges proportionalt med dosis inden for intervallet 60 mikrogram til 240 mikrogram.
English: Elonva causes the growth and development of several follicles at the same time by a controlled stimulation of the ovaries.
Danish: Elonva medfører vækst og udvikling af adskillige follikler på samme tid ved en kontrolleret stimulering af æggestokkene.
English: This is a serious medical condition where the ovaries are overly stimulated and the growing follicles become larger than normal.
Danish: Dette er en alvorlig lidelse, hvor æggestokkene bliver overstimulerede, og folliklerne vokser og bliver større end normalt.
English: Two of these four women became pregnant during the same treatment cycle in which antibodies were detected, suggesting that the presence of non-neutralizing antibodies after stimulation with Elonva is not clinically relevant.
Danish: To ud af disse fire kvinder blev gravide i den samme behandlingscyklus, hvor der blev påvist antistoffer, hvilket tyder på, at tilstedeværelse af ikke-neutraliserende antistoffer efter stimulation med Elonva ikke er klinisk relevant.
English: The daily dose of (rec)FSH may depend on the ovarian response.
Danish: Den daglige dosis (rec)FSH kan afhænge af det ovarielle respons.
English: The maximum number of FTET cycles was 5 and 4 for the follow-up FTET trial for ENGAGE and PURSUE, respectively.
Danish: Det maksimale antal FTET-cyklusser var 5 og 4 for det opfølgende FTET-studie for henholdsvis ENGAGE og PURSUE.
English: The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Danish: pH kan være justeret med natriumhydroxid og/eller saltsyre.
English: In each case, these antibodies were non-neutralizing and did not interfere with the response to stimulation or the normal physiologic responses of the Hypothalamic-Pituitary-Ovarian (HPO) axis.
Danish: Der var i alle tilfælde tale om ikke-neutraliserende antistoffer, og de påvirkede ikke respons på stimulation eller det normale fysiologiske respons af hypothalamus-hypofyse-ovarie (HPO)-aksen.
English: OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Danish: OHSS er en medicinsk hændelse, som er forskellig fra ukompliceret forstørrelse af ovarierne.
English: Severe OHSS may be life-threatening.
Danish: Svær OHSS kan være livstruende.
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: Subcutaneous injection of Elonva may be carried out by the woman herself or her partner, provided that proper instructions are given by the physician.
Danish: Subkutan injektion af Elonva kan foretages af patienten selv eller hendes partner, forudsat at lægen har givet tilstrækkelig vejledning.
English: Elonva contains sodium
Danish: Elonva indeholder natrium
English: It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
Danish: Det skal dog bemærkes, at en graviditet i sig selv medfører en forhøjet risiko for trombose.
English: Of the 2,511 women treated with Elonva who were evaluated for the formation of post-treatment antibodies, four (0.16%) had evidence of antibody formation, including three who had been exposed once to Elonva and one who had been exposed twice to Elonva.
Danish: Ud af de 2.511 kvinder, som blev behandlet med Elonva og vurderet for dannelse af antistoffer efter behandlingen, viste fire kvinder (0,16%) tegn på antistofdannelse, herunder tre kvinder, som havde været eksponeret for Elonva en gang, og en kvinde, som havde været eksponeret for Elonva to gange.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Elonva.
Danish: Sygdomme, som kontraindicerer graviditet, bør også vurderes før påbegyndelse af behandling med Elonva.
English: *Live birth rate was a secondary efficacy endpoint in ENGAGE and PURSUE.
Danish: *Antal levendefødte børn var et sekundært virkningsendepunkt i ENGAGE og PURSUE.
English: Due to the long elimination half-life, after administration of the recommended dose, serum concentrations of corifollitropin alfa are sufficient to sustain multiple follicular growth for an entire week.
Danish: På grund af den lange eliminationshalveringstid efter administration af den anbefalede dosis er serumkoncentrationer af corifollitropin alfa tilstrækkelige til at opretholde multipel follikulær udvikling i en hel uge.
English: Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART).
Danish: Følg gældende kliniske praksis for at reducere risikoen for OHSS ved assisteret reproduktionsbehandlingsteknologi (ART).
English: In normal responders a daily dose of 150 IU (rec)FSH is advised.
Danish: Hos normale respondenter anbefales en daglig dosis på 150 IE (rec)FSH.
English: Mean number of oocytes Difference [95% CI]
Danish: Gennemsnitligt antal oocytter Forskel [95% CI]
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 gonadotropiner opvejes mod risici.
English: Pharmacokinetic parameters of corifollitropin alfa were evaluated after subcutaneous administration in women undergoing a COS treatment cycle.
Danish: Corifollitropin alfas farmakokinetiske parametre blev vurderet efter subkutan administration hos kvinder, der gennemførte en COS-behandlingscyklus.
English: To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be useful.
Danish: For at overvåge risikoen for OHSS skal der udføres ultralydsundersøgelser af follikeludviklingen før behandlingen og med regelmæssige intervaller under behandlingen; samtidig bestemmelse af estradiol i serum kan også være nyttig.
English: Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity.
Danish: Corifollitropin alfa er udviklet som en vedvarende follikelstimulant med samme farmakodynamiske profil som (rec)FSH, men med en markant forlænget varighed af FSH aktivitet.
English: Gonadotropic hormones play an important role in human fertility and reproduction.
Danish: Gonadotropiner spiller en vigtig rolle for frugtbarhed og forplantning hos mennesker.
English: Distribution, metabolism and elimination of corifollitropin alfa are very similar to other gonadotropins, such as FSH, hCG and LH.
Danish: Fordeling, metabolisme og elimination af corifollitropin alfa er sammenlignelig med andre gonadotropiner såsom FSH, hCG og LH.
English: You may use Elonva only once during the same treatment cycle, otherwise, the chance of having OHSS may increase.
Danish: Du må kun tage Elonva en gang i samme behandlingscyklus, da risikoen for OHSS ellers øges.
English: Stimulation day 1:
Danish: Stimulationsdag 1:
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 skyldes forskelle i forældrenes karakteristika (f.eks. moderens alder, sædkvalitet) og den øgede hyppighed af flerfoldsgraviditeter.
English: Older than 36 years
Danish: Over 36 år
English: The relevance of these findings for the clinical use of Elonva is limited.
Danish: Relevansen af disse fund er begrænset for den kliniske brug af Elonva.
English: In rare cases, severe OHSS may be life-threatening.
Danish: I sjældne tilfælde kan svær OHSS være livstruende.
English: Women older than 36 years of age who weighed less than 50 kilograms were not studied.
Danish: Kvinder, som var ældre end 36 år og vejede mindre end 50 kilogram, blev ikke undersøgt.
English: Stimulation day 8:
Danish: Stimulationsdag 8:
English: Clear and colourless aqueous solution.
Danish: Klar og farveløs vandig opløsning.
English: The table below displays the main adverse reactions in women treated with Elonva in clinical trials and post-marketing surveillance according to system organ class and frequency; 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), and not known (cannot be estimated from available data).
Danish: Tabellen nedenfor viser de primære bivirkninger hos kvinder behandlet med Elonva i kliniske studier og efter markedsføring opstillet efter systemorganklasser og frekvens; 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).