FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
Danish: Der er spontant rapporteret synsdefekter i forbindelse med indtagelse af sildenafil og andre PDE5-hæmmere (se pkt.
English: Mysildecard should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Danish: Mysildecard må ikke gives til kvinder i den fødedygtige alder, medmindre der anvendes sikker prævention.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Danish: AUC og Cmax-værdierne for N-desmethylmetabolitten er yderligere signifikant forhøjet med hhv. 154% og 87% hos cirrotiske forsøgspersoner sammenlignet med forsøgspersoner med normal leverfunktion.
English: If you forget to take Mysildecard
Danish: Hvis De har glemt at tage Mysildecard
English: A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
Danish: En populationsfarmakokinetisk analyse af data fra kliniske studier med sildenafil hos voksne PAH-patienter, herunder et 12-ugers studie, der vurderede effekten og sikkerheden af 20 mg sildenafil oralt 3 gange dagligt som tillæg til en stabil dosis bosentan (62,5-125 mg 2 gange dagligt), indikerede et fald i eksponeringen for sildenafil ved samtidig administration af bosentan, som svarede til det, der sås hos raske frivillige forsøgspersoner (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg sildenafil (som citrat).
English: In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Danish: Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance <30 ml/min) reduceres sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på hhv. 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
English: A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steadystate sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Danish: En populationsfarmakokinetisk analyse af data fra et studie med voksne PAH-patienter, som fik baggrundsbehandling med bosentan (62,5 - 125 mg 2 gange dagligt), indikerede en stigning i AUC (20% (95% CI: 9,8-30,8) for bosentan ved samtidig administration af steady-state sildenafil (20 mg 3 gange dagligt), som er mindre end den, der ses hos raske frivillige forsøgspersoner ved samtidig administration af 80 mg sildenafil 3 gange dagligt (se pkt.
English: Warnings and precautions Talk to your doctor before taking Mysildecard if you:
Danish: Kontakt lægen, før De tager Mysildecard, hvis De
English: In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomised to placebo.
Danish: I det pivotale placebo-kontrollerede studie af sildenafil ved pulmonal arteriel hypertension blev i alt 207 patienter randomiseret til behandling med 20 mg, 40 mg eller 80 mg sildenafil 3 gange dagligt, og 70 patienter blev randomiseret til placebo.
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section
Danish: Samtidig administration af sildenafil hos patienter, der er i alfa-blokker-behandling, kan hos følsomme patienter føre til symptomatisk hypotension (se pkt.
English: The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; whilst the low dose group showed little difference from placebo (difference of 1.6 mmHg).
Danish: Middel- og højdosis-grupperne viste ændringer i mPAP fra baseline sammenlignet med placebo på hhv. -3,5 mmHg (95% CI: -8,9; 1.9) og -7,3 mmHg (95% CI: -12,4; -2,1), mens lavdosis-gruppen viste en lille forskel fra placebo (1,6 mmHg).
English: INFORMATION IN BRAILLE Mysildecard 20 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Mysildecard 20 mg tablet
English: This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
Danish: Dette lægemiddel bruges til at behandle pulmonal arteriel hypertension (højt blodtryk i lungerne) og kronisk tromboembolisk pulmonal hypertension (højt blodtryk i lungerne som følge af blodpropper).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mmHg (p = 0.01) and -5.1 mmHg (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Danish: Placebokorrigeret behandlingseffekt af mPAP var -2,7 mmHg (p=0,04), -3,0 mmHg (p=0,01) og -5,1 mmHg (p<0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg 3 gange dagligt.
English: If you stop taking Mysildecard
Danish: Hvis De holder op med at tage Mysildecard
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food.
Danish: Den anbefalede dosis til børn og unge i alderen 1-17 år er 10 mg 3 gange dagligt ved legemsvægt 20 kg eller derunder og 20 mg 3 gange dagligt ved legemsvægt over 20 kg. Mysildecard kan tages sammen med eller uden mad.
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Danish: Placebokorrigeret behandlingseffekt af PVR var -178 dyn.sek/cm5 (p=0,0051), -195 dyn.sek/cm5 (p=0,0017) og -320 dyn.sek/cm5 (p<0,0001) for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt.
English: Subjects who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing > 20 kg entered the low, medium or high dose groups (1:1:1).
Danish: Forsøgspersoner, der vejede ≤ 20 kg, blev inkluderet i middel- eller højdosisgruppen (1:1), mens forsøgspersoner, der vejede > 20 kg, blev inkluderet i lav-, middel- eller højdosisgruppen (1:1:1).
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Danish: Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4-hæmmer, i steady-state (500 mg 2 gange daglig i 5 dage) ses en 182% stigning i optagelsen af sildenafil (AUC).
English: The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Danish: Følgende alvorlige bivirkninger betragtes som forbundet med behandlingen og er ikke almindelige (det sker hos mellem 1 og 10 ud af 100 patienter): allergisk reaktion (såsom hududslæt, hævelser i ansigt, læber og tunge, hvæsende vejrtrækning, åndedrætsbesvær og synkebesvær), kramper, uregelmæssig puls, nedsat hørelse, åndenød, betændelseslignende reaktion i mave-tarmkanalen og hvæsende vejrtrækning pga. blokering af luftvejene.
English: Ear and labyrinth disorders Common vertigo
Danish: Øre og labyrint Almindelig Ikke kendt vertigo pludseligt høretab
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold)increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Danish: Samtidig indgift med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450 hæmmer, ved steady-state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1.000% (11 gange).
English: Placebo corrected increases in 6MWD were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Danish: Placebo-korrigeret stigning i 6MWD var 45 meter (p<0,0001), 46 meter (p<0,0001) og 50 meter (p<0,0001) for hhv. sildenafil 20 mg, 40 mg og 80 mg. Der var ingen signifikant forskel i effekten mellem sildenafildoserne.
English: Mysildecard 20 mg film-coated tablets sildenafil
Danish: Mysildecard 20 mg filmovertrukne tabletter sildenafil
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Danish: Læs indlægssedlen før brug.
English: Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93% and 85% in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Danish: Kaplan-Meier-estimat af overlevelse efter 3 år for patienter >20 kg ved baseline var hhv. 94%, 93% og 85% for lav-, middel- og højdosis-grupperne.
English: Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion
Danish: Luftveje, thorax og mediastinum Almindelig epistaxis, hoste, tilstopning af næsen
English: A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Danish: I alt 106 ud af 234 (45%) forsøgspersoner kunne evalueres ved CPET, hvilket omfattede børn ≥7 år, som udviklingsmæssigt var i stand til at udføre testen.
English: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including the combined use of sildenafil for erectile dysfunction has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
Danish: Samtidig anvendelse med andre PDE5-hæmmere Sildenafils sikkerhed og effekt ved samtidig anvendelse af andre PDE5-hæmmere, herunder kombineret brug af sildenafil til erektil dysfunktion, er ikke undersøgt hos patienter med pulmonal arteriel hypertension og samtidig anvendelse kan ikke anbefales (se pkt.
English: PVC-Al blisters unit dose perforated blister pack containing 90 x 1 film-coated tablets.
Danish: PVC-Al blistere enhedsdosis perforeret blisterpakke indeholdende 90 × 1 filmovertrukket tablet Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: What Mysildecard contains - The active substance is sildenafil.
Danish: - Aktivt stof: sildenafil.
English: For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Danish: Hos patienter med en baseline gangdistance på 325 m var behandlingseffekten 38,4 m til sildenafils fordel.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg)
Danish: I et lille placebo-kontrolleret studie på patienter med dokumenteret tidlig aldersbetinget makulær degeneration (n=9), sildenafil (100 mg enkeltdosis) ses der ingen signifikante ændringer i udførte synsundersøgelser (synsskarphed, farveskelnen ved simuleret trafiklys, Humphrey perimeter og fotostress).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter recept (Se bilag I: Produktresumé, se pkt.
English: Adverse reactions which occurred in > 1% of sildenafil-treated patients and were more frequent (> 1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1 /1,000 to < 1/100) and not known (cannot be estimated from the available data).
Danish: Bivirkninger, der forekommer hos >1% af sildenafil-behandlede patienter, og som er hyppigere (>1% forskel) for sildenafil i pivotal-studiet eller i det sildenafilkombinerede datasæt for begge placebo-kontrollerede studier med pulmonal arteriel hypertension i doser på 20 mg, 40 mg eller 80 mg 3 gange dagligt, er anført i skemaet nedenfor.
English: NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Mysildecard 20 mg filmovertrukne tabletter
English: Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
Danish: Puh/Tel: +358 20 720 9555
English: How to take Mysildecard
Danish: Sådan skal De tage Mysildecard
English: if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours.
Danish: Hvis De oplever en af følgende bivirkninger, skal De stoppe med at tage Mysildecard og straks søge læge (se også afsnit 2): - pludseligt nedsat syn eller synstab (hyppighed er ukendt) - erektion, som varer uafbrudt i mere end 4 timer.
English: NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets sildenafil
Danish: LÆGEMIDLETS NAVN Mysildecard 20 mg filmovertrukne tabletter sildenafil
English: What Mysildecard is and what it is used for What you need to know before you take Mysildecard How to take Mysildecard
Danish: Det skal De vide, før De begynder at tage Mysildecard Sådan skal De tage Mysildecard Bivirkninger
English: cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
Danish: • har en hvilken som helst sygdom eller deformitet af penis.
English: Most subjects were WHO Functional Class I (75/234, 32%) or II (120/234, 51%) at baseline; fewer patients were Class III (35/234, 15%) or IV (1/234, 0.4%); for a few patients (3/234, 1.3%), the WHO Functional Class was unknown.
Danish: De fleste forsøgspersoner var WHO-funktionsklasse I (75/234, 32%) eller II (120/234, 51%) ved baseline.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig pyreksi
English: • Severe hepatic impairment,
Danish: • Svært nedsat leverfunktion,
English: Musculoskeletal and connective tissue disorders Very common pain in extremity
Danish: Knogler, led, muskler og bindevæv Meget almindelig ekstremitetssmerter
English: Mysildecard can cause a serious increase in the effects of these medicines.
Danish: Mysildecard kan øge disse præparaters virkning i uønsket, alvorlig grad. Fortæl Deres læge, hvis De tager nogle af disse præparater.
English: BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Danish: Ikke almindelig Ikke kendt retinablødning, nedsat syn, sløret syn, fotofobi, chromatopsia, cyanopsia, øjenirritation, okulær hyperæmi uskarpt syn, dobbeltsyn, usædvanlig følelse i øjet non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, synsfeltdefekt*
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Danish: Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en CYP450-hæmmer og ikke specifik CYP3A4-hæmmer, en
English: Between 20% and 31% of the women became pregnant.
Danish: Mellem 20 % og 31 % af kvinderne blev gravide.
English: Overall, the values for the GnRH agonists were slightly higher.
Danish: Generelt var værdierne for GnRHantagonisterne en smule højere.
English: The full EPAR for Orgalutran can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Orgalutran findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patient or her partner may give the injections themselves, if they have been trained and have access to expert advice.
Danish: Patienten eller hendes partner kan selv foretage indsprøjtningerne, hvis de har fået vist teknikken og har adgang til ekspertrådgivning.
English: This document is a summary of the European Public Assessment Report (EPAR) for Orgalutran.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Orgalutran.
English: Treatment with Orgalutran should be carried out by a doctor who has experience in this type of fertility treatment.
Danish: Behandling med Orgalutran bør udføres af en læge med erfaring i denne type fertilitetsbehandling.
English: After treatment with Orgalutran, the average number of eggs that could be harvested was between 7.9 and 11.6 per woman.
Danish: Efter behandling med Orgalutran lå det gennemsnitlige antal æg, der kunne udtages, på mellem 7,9 og 11,6 pr. kvinde.
English: The main measures of effectiveness were the number of eggs that could be harvested and the number of women who became pregnant.
Danish: Det vigtigste mål for virkningen var det antal æg, der kunne udtages, og antallet af kvinder, der blev gravide.
English: Orgalutran is given as a single 0.25-mg injection under the skin once a day.
Danish: Orgalutran gives som en enkelt 0,25-mg-injektion under huden en gang dagligt.
English: The ability of Orgalutran to prevent premature ovulation has been studied in three main studies involving 1,335 women.
Danish: Virkningen af Orgalutran til forebyggelse af for tidlig ægløsning er blevet undersøgt i tre hovedundersøgelser, der omfattede 1 335 kvinder.
English: Sometimes, the ovaries can over-respond to stimulation.
Danish: Ovarierne kan undertiden overreagere på stimulationen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orgalutran.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Orgalutran.
English: Other information about Orgalutran:
Danish: Andre oplysninger om Orgalutran:
English: Each syringe contains 0.25 mg of the active substance, ganirelix.
Danish: Hver injektionssprøjte indeholder 0,25 mg af det aktive stof ganirelix.
English: It must not be used by women who are pregnant or breast-feeding, or in women with moderate or severe kidney or liver disease.
Danish: Lægemidlet må ikke anvendes til kvinder, som er gravide eller ammer, eller til kvinder med moderat eller svær nyre- eller leversygdom.
English: For more information about treatment with Orgalutran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Orgalutran, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orgalutran to N.V. Organon on 17 May 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orgalutran til N.V.
English: During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more than one egg.
Danish: Under fertilitetsbehandling anvendes ovariestimulation normalt til at få ovarierne til at producere mere end ét æg.
English: When treatment should start depends on how well the ovaries are responding to stimulation.
Danish: Tidspunktet for behandlingsstart afhænger af, hvor godt æggestokkene reagerer på stimuleringen.
English: In premature ovulation, the ovaries release eggs that may be immature and not suitable for use in techniques such as in-vitro fertilisation.
Danish: Ved præmatur ægløsning frigiver æggestokkene æg, som kan være umodne og uegnede til anvendelse til teknikker som f.eks. in vitro-befrugtning.
English: The CHMP decided that Orgalutran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ornalutran er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Orgalutran.
English: In studies, the most common side effect with Orgalutran (seen in more than 1 patient in 10) was a skin reaction at the injection site, mainly redness with or without swelling.
Danish: I undersøgelserne var den hyppigste bivirkning ved Orgalutran (som optræder hos flere end 1 ud af 10 patienter) en hudreaktion på injektionsstedet, hovedsageligt rødme med eller uden hævelse.
English: Treatment should start on day 5 or 6 after the start of ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin alfa (a modified FSH).
Danish: Behandlingen bør indledes på den 5. eller 6. dag efter påbegyndt ovariestimulation med follikelstimulerende hormon (FSH) eller corifollitropin alfa (et modificeret FSH).
English: The active substance in Orgalutran, ganirelix, blocks the receptors for a natural hormone called gonadotrophin-releasing hormone (GnRH).
Danish: Det aktive stof i Orgalutran, ganirelix, blokerer receptorerne for et naturligt hormon kaldet gonadotrophinfrigørende hormon (GnRH).
English: What is the risk associated with Orgalutran?
Danish: Hvilken risiko er der forbundet med Orgalutran?
English: Treatment with Orgalutran should be continued up to the day that there are enough large follicles (small sacs in the ovary that hold the eggs).
Danish: Behandlingen med Orgalutran bør fortsættes, indtil der er nok store follikler (små sække i æggestokkene, som indeholder æggene).
English: Orgalutran is preferably given into the upper leg.
Danish: Orgalutran skal fortrinsvis indgives i låret.
English: Why has Orgalutran been approved?
Danish: Hvorfor blev Orgalutran godkendt?