FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan optræde hos op til 1 ud af 10.000 behandlede)
English: • Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty in breathing may occur.
Danish: • Overfølsomhedsreaktioner, som f.eks. udslæt, rødmen af huden, nældefeber, hævelse i ansigtet med vejrtrækningsbesvær, kan forekomme.
English: • The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) together with 75 IU (0.12 mL) of lutropin alfa.
Danish: • Den sædvanlige startdosis er 75-150 IE (0,12-0,25 ml) Bemfola sammen med 75 IE (0,12 ml) lutropin alfa.
English: Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum estrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Danish: Behandlingen fortsætter med en dosis tilpasset patientens respons, sædvanligvis ikke højere end 450 IE/dag, til tilstrækkelig follikeludvikling er opnået (vurderet ved kontrol af serumøstrogen og/eller ultralydsundersøgelse).
English: The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Danish: De hyppigst rapporterede bivirkninger er hovedpine, ovariecyster og lokale reaktioner på injektionsstedet (f.eks. smerte, erytem, hæmatom, hævelse og/eller irritation på injektionsstedet).
English: Replace the outer needle cap onto the needle carefully.
Danish: Sæt forsigtigt den ydre kanylehætte på kanylen igen.
English: Bemfola 75 IU/0.125 mL pre-filled pen Bemfola 150 IU/0.25 mL pre-filled pen Bemfola 225 IU/0.375 mL pre-filled pen
Danish: Bemfola, fyldt pen, 75 IE/0,125 ml Bemfola, fyldt pen, 150 IE/0,25 ml Bemfola, fyldt pen, 225 IE/0,375 ml
English: How to use the Bemfola pre-filled pen
Danish: Sådan skal du bruge Bemfola fyldt pen
English: • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Danish: • Follitropin alfa er indiceret i kombination med behandling med humant choriongonadotropin (hCG) til stimulation of spermatogenesen hos mænd, som har medfødt eller erhvervet hypogonadotrop hypogonadisme.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Danish: Abdominalsmerter, oppustet abdomen, abdominalt ubehag, kvalme, opkastning,
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan optræde hos mere end 1 ud af 10 behandlede)
English: Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children).
Danish: Hvis du har porfyri, eller nogen i din familie har porfyri (manglende evne til at nedbryde porfyrin, hvilket kan nedarves fra forældre til børn), skal du fortælle det til lægen, inden du starter behandlingen.
English: In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Danish: I kliniske forsøg så man en øget ovariefølsomhed over for follitropin alfa, når det blev indgivet sammen med lutropin alfa.
English: Women with anovulation resulting from severe LH and FSH deficiency In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG).
Danish: Hos kvinder med mangel på LH og FSH (hypogonadotropisk hypogonadisme) er formålet med follitropin alfa-behandling i forbindelse med lutropin alfa at udvikle en enkelt Graafsk follikel, fra
English: In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of follitropin alfa.
Danish: Der foreligger ikke tilstrækkelige kliniske data til at udelukke teratogen effekt af follitropin alfa i tilfælde af eksponering under graviditet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/03/2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Danish: En enkelt injektion på 250 mikrogram r-hCG eller 5.000 IE og op til 10.000 IE hCG administreres 24-28 timer efter sidste injektion af follitropin alfa for at inducere afsluttende follikulær modning.
English: For example, after two weeks of GnRH agonist treatment, 150 to 225 IU Bemfola is administered for 7 days.
Danish: 150-225 IE Bemfola gives f.eks. i 7 dage efter to uger med GnRH-agonistbehandling.
English: Do not push the dosage knob in while attaching the needle.
Danish: Undgå at trykke doseringsknappen ind, når du sætter kanylen på.
English: • Sacs of fluid within the ovaries (ovarian cysts)
Danish: • Væskefyldte hulrum i æggestokkene (ovariecyster)
English: Bemfola 300 IU/0.50 mL pre-filled pen Bemfola 450 IU/0.75 mL pre-filled pen
Danish: Bemfola, fyldt pen, 300 IE/0,50 ml Bemfola, fyldt pen, 450 IE/0,75 ml
English: • tumours of the hypothalamus or pituitary gland;
Danish: • tumor i hypotalamus eller hypofyse
English: Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and mediastinal disorders Very rare:
Danish: Tromboemboli (både i forbindelse med og uden samtidigt OHSS) Luftveje, thorax og mediastinum
English: Bemfola 75 IU/0.125 mL (5.5 micrograms/0.125 mL) is not designed to allow the cartridge to be removed.
Danish: Bemfola 75 IE/0,125 ml (5,5 mikrogram/0,125 ml) pen er ikke konstrueret til, at cylinderampullen kan fjernes.
English: INFORMATION IN BRAILLE Bemfola 225 IU/0.375 mL
Danish: INFORMATION I BRAILLESKRIFT Bemfola 225 iu/0,375 ml
English: INFORMATION IN BRAILLE Bemfola 75 IU/0.125 mL
Danish: INFORMATION I BRAILLESKRIFT Bemfola 75 iu/0,125 ml
English: INFORMATION IN BRAILLE Bemfola 300 IU/0.5 mL
Danish: INFORMATION I BRAILLESKRIFT Bemfola 300 iu/0,5 ml
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies A commonly used regimen for superovulation involves the administration of 150-225 IU of follitropin alfa daily commencing on days 2 or 3 of the cycle.
Danish: En almindeligt anvendt dosering for superovulation omfatter administration af 150-225 IE follitropin alfa pr. dag med start på dag 2 eller 3 af cyklus.
English: Ectopic pregnancy
Danish: Ekstrauterin graviditet
English: Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Gedeon Richter Plc.
English: Each prefilled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.
Danish: Hver fyldt pen giver 150 IE (svarende til 11 µg) i 0,25 ml.
English: Each prefilled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
Danish: Hver fyldt pen giver 75 IE (svarende til 5,5 µg) i 0,125 ml.
English: Complication of severe OHSS General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Danish: Gynækomasti, varikocele Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Reaktioner på injektionsstedet (f.eks. smerte, erytem, hæmatom, hævelse og/eller irritation på injektionsstedet)
English: If you use more Bemfola than you should
Danish: Hvis du har brugt for meget Bemfola
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Gedeon Richter Plc.
English: Reproductive system neoplasms
Danish: Reproduktionssystemtumorer
English: Each prefilled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
Danish: Hver fyldt pen giver 225 IE (svarende til 16,5 µg) i 0,375 ml.
English: INFORMATION IN BRAILLE Bemfola 450 IU/0.75 mL
Danish: INFORMATION I BRAILLESKRIFT Bemfola 450 iu/0,75 ml
English: • Bemfola 150 IU/0.25 mL: Each cartridge contains 150 IU (equivalent to 11 micrograms) follitropin alfa in 0.25 mL solution.
Danish: • Bemfola, 150 IE/0,25 ml: Hver cylinderampul indeholder 150 IE (svarende til 11 µg) follitropin alfa i 0,25 ml opløsning.
English: • Bemfola 75 IU/0.125 mL: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) follitropin alfa in 0.125 mL solution.
Danish: • Bemfola, 75 IE/0,125 ml: Hver cylinderampul indeholder 75 IE (svarende til 5,5 µg) follitropin alfa i 0,125 ml opløsning.
English: Bemfola 150 IU/0.25 mL (11 micrograms/0.25 mL) is not designed to allow the cartridge to be removed.
Danish: Bemfola 150 IE/0,25 ml (11 mikrogram/0,25 ml) pen er ikke konstrueret til, at cylinderampullen kan fjernes.
English: INFORMATION IN BRAILLE Bemfola 150 IU/0.25 mL
Danish: INFORMATION I BRAILLESKRIFT Bemfola 150 iu/0,25 ml
English: Posology
Danish: INDHOLD
English: Solution for injection 1 pre-filled pen 1 injection needle 1 alcohol swab
Danish: 1 injektionskanyle 1 spritserviet
English: • Bemfola 225 IU/0.375 mL: Each cartridge contains 225 IU (equivalent to 16.5 micrograms) follitropin alfa in 0.375 mL solution.
Danish: • Bemfola, 225 IE/0,375 ml: Hver cylinderampul indeholder 225 IE (svarende til 16,5 µg) follitropin alfa i 0,375 ml opløsning.
English: Bemfola 225 IU/0.375 mL (16.5 micrograms/0.375 mL) is not designed to allow the cartridge to be removed.
Danish: Bemfola 225 IE/0,375 ml (16,5 mikrogram/0,375 ml) pen er ikke konstrueret til, at cylinderampullen kan fjernes.
English: If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Danish: Hvis et for kraftigt respons opnås, bør behandlingen stoppes og hCG seponeres (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.125 mL
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,125 ml
English: • Anovulation (including polycystic ovariansyndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate.
Danish: polycystisk ovariesyndrom, PCOS) hos kvinder, som ikke har reageret på behandling med clomifencitrat.
English: • Before starting to use your pre-filled pen, please read these instructions and the package leaflet the whole way through first.
Danish: • Læs hele vejledningen og indlægssedlen igennem, inden du starter med at bruge din fyldte pen.
English: When an optimal response is obtained, a single injection of 250 micrograms of recombinant human chorionic gonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Danish: Når et optimalt respons er opnået, gives en enkelt injektion på 250 mikrogram rekombinant humant choriongonadotropin alfa (r-hCG) eller 5.000 IE hCG og op til 10.000 IE hCG 24-48 timer efter den sidste injektion af follitropin alfa.
English: When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Danish: Når optimal respons er opnået, gives en enkelt injektion af 250 mikrogram r-hCG eller 5.000 IE og op til 10.000 IE hCG 24-48 timer efter de sidste injektioner af follitropin alfa og lutropin alfa.
English: Each prefilled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Danish: Hver fyldt pen giver 450 IE (svarende til 33 µg) i 0,75 ml.
English: Bemfola 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Danish: Bemfola 450 IE/0,75 ml (33 mikrogram/0,75 ml) pen er ikke konstrueret til, at cylinderampullen kan fjernes.
English: The patient is recommended to have coitus on the day of, and on the day following hCG administration.
Danish: Patienten bør have coitus på selve dagen og på dagen efter hCG-indgivelsen.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis du har yderligere spørgsmål om brugen af denne medicin.
English: Treatment in men Immune system disorders Very rare:
Danish: Meget almindelige: Hovedpine Vaskulære sygdomme Meget sjælden:
English: • Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Danish: • Kvalme, opkastning, diarré, mavekramper og oppustet mave
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last Bemfola injection.
Danish: • Når du opnår den ønskede virkning, vil du få en enkelt injektion på 250 mikrogram “rekombinant hCG” (r-hCG, et hCG, som er fremstillet i et laboratorium ved en særlig DNAteknik) eller 5.000 til 10.000 IE hCG 24 til 48 timer efter den sidste Bemfola-injektion.
English: • Bemfola 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Danish: • Bemfola, 450 IE/0,75 ml: Hver cylinderampul indeholder 450 IE (svarende til 33 µg) follitropin alfa i 0,75 ml opløsning.
English: Each prefilled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.
Danish: Hver fyldt pen giver 300 IE (svarende til 22 µg) i 0,5 ml.
English: • Bemfola 300 IU/0.50 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 mL solution.
Danish: • Bemfola, 300 IE/0,50 ml: Hver cylinderampul indeholder 300 IE (svarende til 22 µg) follitropin alfa i 0,50 ml opløsning.
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of Bemfola and lutropin alfa.
Danish: • Når du får den ønskede virkning, vil du få en enkelt injektion af 250 mikrogram ”rekombinant hCG” (r-hCG, et hCG, som er fremstillet i et laboratorium ved en særlig DNA-teknik) eller 5.000-10.000 IE hCG 24-48 timer efter de sidste injektioner af Bemfola og lutropin alfa.
English: Follitropin alfa is not indicated during breastfeeding.
Danish: Amning Follitropin alfa er ikke indiceret til ammende kvinder.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.375 mL
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,375 ml
English: CONTENTS
Danish: TILLADELSEN
English: Bemfola 300 IU/0.50 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
Danish: Bemfola 300 IE/0,50 ml (22 mikrogram/0,5 ml) pen er ikke konstrueret til, at cylinderampullen kan fjernes.
English: Miscarriage
Danish: Vægtøgning
English: Remove the inner needle cap.
Danish: Aftag den indvendige beskyttelseshætte på kanylen.
English: Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Danish: Bemfola, injektionsvæske, opløsning, 75 IE/0,125 ml, i fyldt pen Bemfola, injektionsvæske, opløsning, 150 IE/0,25 ml, i fyldt pen Bemfola, injektionsvæske, opløsning, 225 IE/0,375 ml, i fyldt pen
English: Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen giver 450 IU follitropin alfa, svarende til 33 µg pr. 0,75 ml.
English: Each cartridge contains 0.375 mL solution for injection.
Danish: Hver cylinderampul indeholder 0,375 ml injektionvæske, opløsning.
English: Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen giver 150 IU follitropin alfa, svarende til 11 µg pr. 0,25 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 225 IU/0.375 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Bemfola 225 IU/0,375 ml injektionsvæske follitropin alfa
English: What Bemfola is and what it is used for What you need to know before you use Bemfola How to use Bemfola
Danish: Det skal du vide, før du begynder at bruge Bemfola Sådan skal du bruge Bemfola Bivirkninger
English: Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen giver 300 IU follitropin alfa, svarende til 22 µg pr. 0,5 ml.
English: What Bemfola looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Do not twist it on. You will hear a click when it is securely fixed.
Danish: Du vil høre et klik, når kanylen sidder korrekt fast.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan optræde hos op til 1 ud af 10 behandlede)
English: Breastfeeding
Danish: Phosphorsyre
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 300 IU/0.5 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Bemfola 300 IU/0,5 ml injektionsvæske follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 75 IU/0.125 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Bemfola 75 IU/0,125 ml injektionsvæske follitropin alfa
English: Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen giver 225 IU follitropin alfa, svarende til 16,5 µg pr. 0,375 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 450 IU/0.75 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Bemfola 450 IU/0,75 ml injektionsvæske follitropin alfa
English: Very common: Headache
Danish: Meget almindelig: Ovariecyster
English: Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Danish: Eksacerbationer eller forværring af astma
English: Fertility
Danish: Dosering
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 150 IU/0.25 mL injection follitropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ(E) Bemfola 150 IU/0,25 ml injektionsvæske follitropin alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mL
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,25 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,75 ml
English: Each pre-filled pen delivers 75 IU follitropin alfa, equivalent to 5.5 micrograms per 0.125 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen giver 75 IU follitropin alfa, svarende til 5,5 µg pr. 0,125 ml.
English: Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola, injektionsvæske, opløsning, 300 IE/0,50 ml, i fyldt pen Bemfola, injektionsvæske, opløsning, 450 IE/0,75 ml, i fyldt pen follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola 225 IE/0,375 ml injektionsvæske, opløsning i fyldt pen follitropin alfa
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Danish: Follitropin alfa kan gives som et forløb med daglige injektioner.
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.5 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola 300 IU/0,5 ml injektionsvæske, opløsning i fyldt pen follitropin alfa
English: Each cartridge contains 0.25 mL solution for injection.
Danish: Hver cylinderampul indeholder 0,25 ml injektionvæske, opløsning.
English: Congenital malformation
Danish: Medfødte misdannelser
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola 75 IU/0,125 ml injektionsvæske, opløsning, i fyldt pen follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola 150 IE/0,25 ml injektionsvæske, opløsning i fyldt pen follitropin alfa
English: Each cartridge contains 0.5 mL solution for injection.
Danish: Hver cylinderampul indeholder 0, 5 ml injektionvæske, opløsning.
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Danish: Gedeon Richter Plc.
English: Each cartridge contains 0.75 mL solution for injection.
Danish: Hver cylinderampul indeholder 0,75 ml injektionvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Danish: Bemfola 450 IE/0,75 ml injektionsvæske, opløsning i fyldt pen follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Bemfola, injektionsvæske, opløsning, 75 IE/0,125 ml, i fyldt pen
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Bemfola, injektionsvæske, opløsning, 300 IE/0,50 ml, i fyldt pen
English: Setting the dose
Danish: Indstilling af dosis
English: • When your eggs are ready, you will be given a single injection of 250 micrograms “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special recombinant DNA technique), or
Danish: • Når dine æg er klar, vil du få en enkelt injektion af 250 mikrogram ”rekombinant hCG” (rhCG, et hCG, som er fremstillet i et laboratorium ved en særlig rekombinant DNA-teknik) eller 5.000 IE-10.000 IE hCG 24-48 timer efter den sidste Bemfola-injektion.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/909/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/909/002
English: Remove the outer needle cap. Keep it for later.
Danish: Opbevar den til senere brug.
English: Renal or hepatic impairment
Danish: Patienter med nedsat nyre- eller leverfunktion
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Bemfola, injektionsvæske, opløsning, 150 IE/0,25 ml, i fyldt pen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/909/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/909/001
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Bemfola, injektionsvæske, opløsning, 225 IE/0,375 ml, i fyldt pen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/909/003
English: Sodium content
Danish: Natriumindhold
English: Very common (may affect more than 1 in 10 people): • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Danish: Meget almindelig: Reaktioner på injektionsstedet (f.eks. smerte, erytem, hæmatom, hævelse og/eller irritation på injektionsstedet)
English: • Abdominal pain
Danish: • Mavesmerter
English: Value 1
Danish: Værdi 1
English: ¾ The Member States shall ensure that in their Member State:
Danish: ¾ I deres medlemsland skal medlemslandene sikre at:
English: Value 2 X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Danish: Værdi 2 X og Y er dagene (skal fastsættes), hvor målingerne før behandling skal udføres.