FrancophonIA/ELRC3.0 huggingface dataset:
English: When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than if you conceive naturally.
Danish: Graviditet uden for livmoderen (ekstrauterin graviditet) Ved reagensglas-behandling er risikoen for graviditet uden for livmoderen (ekstrauterin graviditet) højere end ved naturlig befrugtning.
English: Keep the cartridge in the REKOVELLE injection pen.
Danish: Behold cylinderampullen i REKOVELLE-injektionspennen.
English: Each cartridge contains 1.08 mL of solution.
Danish: Hver cylinderampul indeholder 1,08 mlinjektionsvæske.
English: REKOVELLE is dosed in micrograms (see section 5.1).
Danish: REKOVELLE doseres i mikrogram (se pkt.
English: Do not throw away any medicines via household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet.
English: The resulting REKOVELLE dosing regimen is in section 4.2.
Danish: Det deraf følgende REKOVELLE-doseringsregime fremgår af pkt.
English: If you use more REKOVELLE than you should
Danish: Hvis du har taget for meget REKOVELLE
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 72 mcg/2.16 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 72 mikrog/2,16 ml
English: • tumours of the hypothalamus or pituitary gland
Danish: • tumor i hypothalamus eller hypofyse
English: Somnolence Dizziness
Danish: Døsighed Svimmelhed
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 36 mcg/1.08 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 36 mikrog/1,08 ml
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 ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: 2 and 1 line (Dial to 2 plus 1 click)
Danish: 2 og 1 linje (Drej til 2 plus 1 klik)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mcg/0.36 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 12 mikrog/0,36 ml
English: 0 and 1 line (Dial to 0 plus 1 click)
Danish: 0 og 1 linje (Drej til 0 plus 1 klik)
English: • you have been told by another doctor that pregnancy would be dangerous for you
Danish: Kontakt lægen, før du bruger dette lægemiddel hvis: - en anden læge har fortalt dig, at en graviditet vil være farlig for dig - du har en nyre- eller leversygdom
English: The cartridge is designed to be used in conjunction with the REKOVELLE injection pen.
Danish: Cylinderampullen er udformet til brug sammen med REKOVELLE injektionspen.
English: The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the pivotal clinical trials according to MedDRA system organ class and frequency as follows: common
Danish: Nedenstående tabel (tabel 2) viser bivirkninger hos patienter behandlet med REKOVELLE i de pivotale kliniske studier.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection REKOVELLE 36 micrograms/1.08 mL solution for injection REKOVELLE 72 micrograms/2.16 mL solution for injection
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning
English: Each cartridge contains 2.16 mL of solution.
Danish: Hver cylinderampul indeholder 2,16 mlinjektionsvæske.
English: After first use: 28 days when stored at or below 25 °C.
Danish: Efter åbning: Kan opbevares i 28 dage ved eller under temperaturer på 25 °C.
English: • you have fibroids of the uterus which make a normal pregnancy impossible.
Danish: - du har nogen former for misdannelser i kønsorganerne, som gør, at det ikke er muligt at gennemføre en normal graviditet - du har fibromer i livmoderen, som gør, at det ikke er muligt at gennemføre en normal graviditet.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning i fyldt pen REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning i fyldt pen REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning i fyldt pen
English: • Pull off the outer needle cap.
Danish: • Træk den ydre nålehætte af.
English: Pelvic pain Adnexa uteri pain Pelvic discomfort
Danish: Bækkensmerter Smerte i adnexa uteri Bækken-ubehag
English: Needles are supplied with your pen.
Danish: Nåle medfølger pennen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 72 micrograms/2.16 mL injection follitropin delta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) REKOVELLE 72 mikrog/2,16 ml injektion follitropin delta s.c.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 36 micrograms/1.08 mL injection follitropin delta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) REKOVELLE 36 mikrog/1,08 ml injektion follitropin delta s.c.
English: What you need to know before you use REKOVELLE 3.
Danish: Det skal du vide, før du begynder at bruge REKOVELLE Sådan skal du bruge REKOVELLE Bivirkninger
English: REKOVELLE 72 micrograms/2.16 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Danish: REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning 3 ml flerdosis-cylinderampul (type-I glas) med et stempel (halobutylgummi) og en beskyttelseshætte (aluminium) med et indlæg (gummi).
English: One millilitre of solution contains 33.3 micrograms of follitropin delta in each millilitre of solution.
Danish: 1 ml opløsning indeholder 33,3 mikrogram follitropin delta.
English: What REKOVELLE looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Each cartridge contains 0.36 mL of solution.
Danish: Hver cylinderampul indeholder 0,36 ml injektionsvæske.
English: Ovarian and other reproductive system tumours
Danish: Tumorer i æggestokke og andre kønsorganer
English: REKOVELLE 36 micrograms/1.08 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Danish: REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning 3 ml flerdosis-cylinderampul (type-I glas) med et stempel (halobutylgummi) og en beskyttelseshætte (aluminium) med et indlæg (gummi).
English: Do not use the pre-filled pen if the solution contains particles or if the solution does not look clear.
Danish: Anvend ikke den fyldte pen, hvis injektionsvæsken indeholder partikler, eller hvis den er uklar.
English: Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Danish: Hver flerdosis-cylinderampul indeholder 36 mikrogram follitropin delta i 1,08 ml injektionsvæske.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Danish: REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning follitropin delta
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution.
Danish: REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning En fyldt flerdosis-pen indeholder 72 mikrogram follitropin delta* i 2,16 ml opløsning.
English: Replace pen cap - (Step 14)
Danish: Påsæt penhætten - (Trin 14)
English: Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Danish: Hver flerdosis-cylinderampul indeholder 72 mikrogram follitropin delta i 2,16 ml injektionsvæske.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 9 pen injection needles
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i fyldt pen 1 flerdosis-fyldt pen og 9 injektionsnåle til pennen
English: REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Danish: REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning follitropin delta
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 6 pen injection needles
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i fyldt pen 1 flerdosis-fyldt pen og 6 injektionsnåle til pennen
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen 1 multidose pre-filled pen with 3 pen injection needles
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i fyldt pen 1 flerdosis-fyldt-pen og 3 injektionsnåle til pennen
English: Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Danish: Hver fyldt pen med flerdosis-cylinderampul indeholder 36 mikrogram follitropin delta i 1,08 ml injektionsvæske.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One multidose cartridge contains 72 micrograms follitropin delta* in 2.16 mL solution.
Danish: REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning En flerdosis-cylinderampul indeholder 72 mikrogram follitropin delta* i 2,16 ml opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 12 micrograms/0.36 mL injection follitropin delta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) REKOVELLE 12 mikrog/0,36 ml injektion follitropin delta s.c.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning follitropin delta
English: 1 multidose cartridge with 9 pen injection needles
Danish: 1 flerdosis-cylinderampul og 9 injektionsnåle til pennen
English: REKOVELLE 12 micrograms/0.36 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning 3 ml flerdosis-cylinderampul (type-I glas) med et stempel (halobutylgummi) og en beskyttelseshætte (aluminium) med et indlæg (gummi).
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution.
Danish: REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning En fyldt flerdosis-pen indeholder 36 mikrogram follitropin delta* i 1,08 ml opløsning.
English: Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Danish: Hver flerdosis-cylinderampul indeholder 12 mikrogram follitropin delta i 0,36 ml injektionsvæske.
English: Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Danish: Hver fyldt pen med flerdosis-cylinderampul indeholder 72 mikrogram follitropin delta i 2,16 ml injektionsvæske.
English: Pack size of 1 cartridge and 9 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Danish: Pakningsstørrelse med 1 cylinderampul og 9 injektionsnåle (rustfrit stål) til anvendelse med REKOVELLE injektionspen.
English: 1 multidose cartridge with 6 pen injection needles
Danish: 1 flerdosis-cylinderampul og 6 injektionsnåle til pennen
English: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta
Danish: REKOVELLE 72 mikrogram/2,16 ml injektionsvæske, opløsning i fyldt pen follitropin delta
English: Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Danish: Pakningsstørrelse med 1 cylinderampul og 6 injektionsnåle (rustfrit stål) til anvendelse med REKOVELLE injektionspen.
English: Needles:
Danish: Nåle:
English: 1 multidose cartridge with 3 pen injection needles
Danish: 1 flerdosis-cylinderampul og 3 injektionsnåle til pennen
English: Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Danish: Pakningsstørrelse med 1 cylinderampul og 3 injektionsnåle (rustfrit stål) til anvendelse med REKOVELLE injektionspen.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One multidose cartridge contains 36 micrograms follitropin delta* in 1.08 mL solution.
Danish: REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning En flerdosis-cylinderampul indeholder 36 mikrogram follitropin delta* i 1,08 ml opløsning.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One multidose cartridge contains 12 micrograms follitropin delta* in 0.36 mL solution.
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning En flerdosis-cylinderampul indeholder 12 mikrogram follitropin delta* i 0,36 ml opløsning.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta
Danish: REKOVELLE 36 mikrogram/1,08 ml injektionsvæske, opløsning i fyldt pen follitropin delta
English: Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Danish: Hver fyldt pen med flerdosis-cylinderampul indeholder 12 mikrogram follitropin delta i 0,36 ml injektionsvæske.
English: Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Danish: Pakningsstørrelse med 1 fyldt pen og 9 injektionsnåle (rustfrit stål).
English: Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
Danish: Pakningsstørrelse med 1 fyldt pen og 3 injektionsnåle (rustfrit stål).
English: When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Danish: Graviditetstab Ved reagensglas behandling er risikoen for abort højere end ved naturlig befrugtning.
English: • you have malformations of the sexual organs which make a normal pregnancy impossible
Danish: - du er kommet tidligt i overgangsalderen - du har nogen former for misdannelser i kønsorganerne, som gør, at det ikke er muligt at gennemføre en normal graviditet - du har fibromer i livmoderen, som gør, at det ikke er muligt at gennemføre en normal graviditet.
English: Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
Danish: Pakningsstørrelse med 1 fyldt pen og 6 injektionsnåle (rustfrit stål).
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning En fyldt flerdosis-pen indeholder 12 mikrogram follitropin delta* i 0,36 ml opløsning.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta
Danish: REKOVELLE 12 mikrogram/0,36 ml injektionsvæske, opløsning i fyldt pen follitropin delta
English: Suomi/Finland Ferring Lääkkeet Oy
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Ferring Pharmaceuticals A/S
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 72 micrograms follitropin delta in 2.16 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt flerdosis-pen indeholder 72 mikrogram follitropin delta i 2,16 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: It is available in packs of 1 pre-filled pen and 9 pen injection needles.
Danish: Det findes i pakning med 1 fyldt pen og 9 injektionsnåle til pennen.
English: It is available in packs of 1 pre-filled pen and 6 pen injection needles.
Danish: Det findes i pakning med 1 fyldt pen og 6 injektionsnåle til pennen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 36 micrograms follitropin delta in 1.08 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt flerdosis-pen indeholder 36 mikrogram follitropin delta i 1,08 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: It is available in packs of 1 pre-filled pen and 3 pen injection needles.
Danish: Det findes i pakninger med 1 fyldt pen og 3 injektionsnåle til pennen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 72 micrograms follitropin delta in 2.16 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver flerdosis-cylinderampul indeholder 72 mikrogram follitropin delta i 2,16 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 36 micrograms follitropin delta in 1.08 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver flerdosis-cylinderampul indeholder 36 mikrogram follitropin delta i 1,08 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each multidose cartridge contains 12 micrograms follitropin delta in 0.36 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver flerdosis-cylinderampul indeholder 12 mikrogram follitropin delta i 0,36 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 12 micrograms follitropin delta in 0.36 mL One mL of solution contains 33.3 micrograms of follitropin delta
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt flerdosis-pen indeholder 12 mikrogram follitropin delta i 0,36 ml En ml opløsning indeholder 33,3 mikrogram follitropin delta
English: It is available in packs of 1 cartridge and 9 pen injection needles.
Danish: Det findes i pakning med 1 cylinderampul og 9 injektionsnåle til pennen.
English: It is available in packs of 1 cartridge and 6 pen injection needles.
Danish: Det findes i pakning med 1 cylinderampul og 6 injektionsnåle til pennen.
English: Do not use the cartridge if the solution contains particles or if the solution does not look clear.
Danish: Anvend ikke cylinderampullen, hvis injektionsvæsken indeholder partikler, eller hvis den er uklar.
English: It is available in packs of 1 cartridge and 3 pen injection needles.
Danish: Det findes i pakninger med 1 cylinderampul og 3 injektionsnåle til pennen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1150/005
English: • Mood swings
Danish: • Humørsvingninger
English: • Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area again before you give your injection.
Danish: Rør ikke dette område igen inden du giver din injektion.
English: • Vaginal bleeding
Danish: • Vaginalblødning
English: • you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian disease)
Danish: - du har en tumor i livmoderen, æggestokkene, brysterne eller hypothalamus - du har forstørrede æggestokke eller cyster på dine æggestokke (medmindre dette skyldes polycystisk ovariesyndrom) - du har blødning fra skeden uden kendt årsag
English: Vomiting
Danish: Humørsvingninger
English: Phenol
Danish: Dosering
English: Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011.
Danish: Gilenya fik en markedsføringstilladelse med gyldighed i hele EU den 17. marts 2011.
English: In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose.
Danish: Agenturet konkluderede desuden, at hjerteaktiviteten hos alle patienter bør kontrolleres nøje efter den første dosis.
English: Gilenya is available as capsules (0.25 mg and 0.5 mg).
Danish: Gilenya fås som kapsler (0,25 mg og 0,5 mg).
English: Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya.
Danish: Yderligere information om Gilenya findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Gilenya.
English: The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.
Danish: Den anbefalede dosis til voksne er én 0,5 mg-kapsel, der tages én gang dagligt gennem munden, og den anbefalede dosis til børn afhænger af kropsvægten.
English: Gilenya contains the active substance fingolimod.
Danish: Gilenya indeholder det aktive stof fingolimod.
English: The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.
Danish: Virkningen blev i alle studier hovedsageligt bedømt på antallet af tilbagefald, patienterne oplevede hvert år.
English: Other information about Gilenya
Danish: Andre oplysninger om Gilenya
English: Women should not become pregnant while taking Gilenya and for two months after treatment has stopped.
Danish: Kvinder bør undgå at blive gravide, mens de tager Gilenya og i to måneder efter behandlingens ophør.
English: As for all medicines, data on the use of Gilenya are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Gilenya løbende overvåget.
English: ‘Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Danish: "Recidiverende-remitterende" betyder, at patienten får tilbagefald af symptomer (recidiv) efterfulgt af perioder med bedring (remission).
English: An overview of Gilenya and why it is authorised in the EU
Danish: En oversigt over Gilenya, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Gilenya?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Gilenya?
English: Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Gilenya vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Gilenya, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The Agency decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Gilenya opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1phosphate receptor, which is involved in controlling the movement of these cells in the body.
Danish: Det sker ved at blokere aktiviteten af en receptor (et mål) på T-cellerne kaldet sphingosin-1-fosfatreceptoren, som er med til at regulere disse cellers bevægelse i kroppen.
English: The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation.
Danish: Virksomheden, der markedsfører Gilenya, vil fremlægge resultaterne af et studie foretaget med henblik på at vurdere risikoen for bivirkninger for hjertet og kredsløbssystemet.
English: Why is Gilenya authorised in the EU?
Danish: Hvorfor blev Gilenya godkendt i EU?
English: Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis.
Danish: Gilenya udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i behandling af multipel sklerose.