FrancophonIA/ELRC3.0 huggingface dataset:
English: When there are 30 or more follicles in total it is advised to withhold hCG administration.
Danish: Det anbefales ikke at administrere hCG, når der er 30 eller flere follikler i alt.
English: Ovarian hyperstimulation syndrome (OHSS)
Danish: Ovarielt overstimulationssyndrom (OHSS)
English: CARTRIDGE TEXT Puregon 900 IU/1.08 mL
Danish: CYLINDERAMPUL TEKST Puregon 900 IE/1,08 ml
English: Ovarian torsion has been reported after treatment with gonadotropins, including Puregon.
Danish: Ovarietorsion er set efter behandling med gonadotropiner, herunder Puregon.
English: Puregon solution for injection is designed for use in conjunction with the Puregon Pen.
Danish: Puregon injektionsvæske, opløsning er fremstillet til brug sammen med en injektionspen kaldet Puregon Pen.
English: CARTRIDGE TEXT Puregon 300 IU/0.36 mL
Danish: CYLINDERAMPUL TEKST Puregon 300 IE/0,36 ml
English: VIAL TEXT Puregon 225 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 225 IE/0,5 ml
English: CARTRIDGE TEXT Puregon 600 IU/0.72 mL
Danish: CYLINDERAMPUL TEKST Puregon 600 IE/0,72 ml
English: After intramuscular or subcutaneous administration of Puregon, maximum concentrations of FSH are reached within about 12 hours.
Danish: Maksimumkoncentrationer af FSH opnås inden for ca. 12 timer efter intramuskulær eller subkutan administration af Puregon.
English: Storage by the pharmacist Store at 2°C - 8°C (in a refrigerator).
Danish: Opbevaring på apoteket Opbevares i køleskab (2 °C - 8 °C ).
English: VIAL TEXT Puregon 75 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 75 IE/0,5 ml
English: OUTER CARTON TEXT Puregon 900 IU/1.08 mL 1 cartridge
Danish: TEKST PÅ YDRE KARTON Puregon 900 IE/1,08 ml 1 cylinderampul
English: Puregon 50 IU/0.5 mL solution for injection Puregon 75 IU/0.5 mL solution for injection Puregon 100 IU/0.5 mL solution for injection Puregon 150 IU/0.5 mL solution for injection Puregon 200 IU/0.5 mL solution for injection Puregon 225 IU/0.5 mL solution for injection follitropin beta
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning Puregon 75 IE/0,5 ml injektionsvæske, opløsning Puregon 100 IE/0,5 ml injektionsvæske, opløsning Puregon 150 IE/0,5 ml injektionsvæske, opløsning Puregon 200 IE/0,5 ml injektionsvæske, opløsning Puregon 225 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Puregon 50 IU/0.5 mL solution for injection Puregon 75 IU/0.5 mL solution for injection Puregon 100 IU/0.5 mL solution for injection Puregon 150 IU/0.5 mL solution for injection Puregon 200 IU/0.5 mL solution for injection Puregon 225 IU/0.5 mL solution for injection
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning Puregon 75 IE/0,5 ml injektionsvæske, opløsning Puregon 100 IE/0,5 ml injektionsvæske, opløsning Puregon 150 IE/0,5 ml injektionsvæske, opløsning Puregon 200 IE/0,5 ml injektionsvæske, opløsning Puregon 225 IE/0,5 ml injektionsvæske, opløsning
English: Puregon 150 IU/0.18 mL solution for injection Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning Puregon 300 IE/0,36 ml injektionsvæske, opløsning Puregon 600 IE/0,72 ml injektionsvæske, opløsning Puregon 900 IE/1,08 ml injektionsvæske, opløsning
English: This corresponds to a strength of 450 IU/mL.
Danish: Dette svarer til en styrke på 450 IE/ml.
English: Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes.For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Danish: Hos anuvolatoriske kvinder, der gennemgår ovulationsinduktion, kan monitorering af follikeludviklingen med transvaginal ultralydsscanning hjælpe med til at bestemme, om behandlingscyklus skal fortsætte eller stoppes for at reducere risikoen for flerfoldsgraviditet.
English: Puregon 150 IU/0.18 mL solution for injection Puregon 300 IU/0.36 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 900 IU/1.08 mL solution for injection follitropin beta
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning Puregon 300 IE/0,36 ml injektionsvæske, opløsning Puregon 600 IE/0,72 ml injektionsvæske, opløsning Puregon 900 IE/1,08 ml injektionsvæske, opløsning follitropin beta
English: OUTER CARTON TEXT Puregon 600 IU/0.72 mL 1 cartridge
Danish: TEKST PÅ YDRE KARTON Puregon 600 IE/0,72 ml 1 cylinderampul
English: Puregon 225 IU/0.5 mL solution for injection
Danish: Puregon 225 IE/0,5 ml injektionsvæske, opløsning
English: What Puregon is and what it is used for What you need to know before you use Puregon How to use Puregon
Danish: Det skal du vide, før du begynder at tage Puregon Sådan skal du tage Puregon Bivirkninger
English: In men who are infertile due to lowered hormone levels, Puregon can be used for the production of sperm.
Danish: Puregon kan stimulere sædproduktionen hos mænd, som er ufrugtbare på grund af nedsat hormonniveau.
English: Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only in order to optimise follicular development but also to reduce the risk of unwanted ovarian hyperstimulation (see section 5.1).
Danish: Dette er ikke kun med henblik på at optimere udviklingen af follikler, men også for at reducere risikoen for uønsket ovarieoverstimulation (se pkt.
English: How to use Puregon
Danish: Sådan skal du tage Puregon
English: Intramuscular (IM) and subcutaneous (SC) use.
Danish: Intramuskulær (i.m.)
English: OUTER CARTON TEXT Puregon 150 IU/0.18 mL 1 cartridge
Danish: TEKST PÅ YDRE KARTON Puregon 150 IE/0,18 ml 1 cylinderampul
English: Store at 2°C - 8°C (in a refrigerator).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: OUTER CARTON TEXT Puregon 300 IU/0.36 mL 1 cartridge
Danish: TEKST PÅ YDRE KARTON Puregon 300 IE/0,36 ml 1 cylinderampul
English: CARTRIDGE TEXT Puregon 150 IU/0.18 mL
Danish: CYLINDERAMPUL TEKST Puregon 150 IE/0,18 ml
English: Puregon 900 IU/1.08 mL injection follitropin beta
Danish: Puregon 900 IE/1,08 ml injektionsvæske follitropin beta s.c.
English: A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
Danish: Mens du stadig trykker, masserer du forsigtigt indsprøjtningsstedet for at fordele Puregon og for at undgå ubehag.
English: Puregon 300 IU/0.36 mL solution for injection EU/1/96/008/038
Danish: Puregon 300 IE/0,36 ml injektionsvæske, opløsning EU/1/96/008/038
English: If you use more Puregon than you should
Danish: Hvis du har taget for meget Puregon
English: Puregon 300 IU/0.36 mL injection follitropin beta
Danish: Puregon 300 IE/0,36 ml injektionsvæske follitropin beta s.c.
English: Puregon 600 IU/0.72 mL injection follitropin beta
Danish: Puregon 600 IE/0,72 ml injektionsvæske follitropin beta s.c.
English: Puregon 900 IU/1.08 mL solution for injection EU/1/96/008/041
Danish: Puregon 900 IE/1,08 ml injektionsvæske, opløsning EU/1/96/008/041
English: VIAL TEXT Puregon 200 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 200 IE/0,5 ml
English: Puregon 150 IU/0.18 mL solution for injection EU/1/96/008/040
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning EU/1/96/008/040
English: In women who do not ovulate and do not respond to treatment with clomifene citrate, Puregon can be used to cause ovulation.
Danish: Puregon kan stimulere ægløsningen hos kvinder, som ikke har ægløsning, og som ikke reagerer på behandling med clomifencitrat.
English: You should use sterile disposable syringes and needles for the administration of Puregon.
Danish: Til injektion af Puregon skal der bruges sterile engangssprøjter og -nåle.
English: Puregon 225 IU/0.5 mL solution for injection EU/1/96/008/032
Danish: Puregon 225 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/032
English: Puregon 75 IU/0.5 mL solution for injection
Danish: Puregon 75 IE/0,5 ml injektionsvæske, opløsning
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 225 IU (450 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Danish: 1 hætteglas indeholder 0,5 ml injektionsvæske med follitropin beta svarende til aktiviteten af 225 IE (450 IE/ml) rekombinant follikelstimulerende hormon (FSH).
English: Puregon 225 IU/0.5 mL injection follitropin beta
Danish: Puregon 225 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Puregon 150 IU/0.18 mL injection follitropin beta
Danish: Puregon 150 IE/0,18 ml injektionsvæske follitropin beta s.c.
English: VIAL TEXT Puregon 50 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 50 IE/0,5 ml
English: OUTER CARTON TEXT Puregon 75 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 75 IE/0,5 ml 1, 5 eller 10 hætteglas
English: Puregon 225 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 225 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 225 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 225 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: VIAL TEXT Puregon 100 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 100 IE/0,5 ml
English: Puregon 75 IU/0.5 mL injection follitropin beta
Danish: Puregon 75 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Puregon 600 IU/0.72 mL solution for injection EU/1/96/008/039
Danish: Puregon 600 IE/0,72 ml injektionsvæske, opløsning EU/1/96/008/039
English: OUTER CARTON TEXT Puregon 225 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 225 IE/0,5 ml 1,5 eller 10 hætteglas
English: Puregon 200 IU/0.5 mL solution for injection EU/1/96/008/029
Danish: Puregon 200 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/029
English: One vial contains 225 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Danish: Et hætteglas indeholder 225 IE rekombinant follikelstimulerende hormon (FSH) i 0,5 ml vandig opløsning.
English: Puregon 75 IU/0.5 mL solution for injection EU/1/96/008/020
Danish: Puregon 75 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/020
English: Puregon 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 75 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 75 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: Puregon 100 IU/0.5 mL solution for injection EU/1/96/008/023
Danish: Puregon 100 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/023
English: One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 1.08 mL aqueous solution.
Danish: Puregon 900 IE/1,08 ml injektionsvæske, opløsning En cylinderampul indeholder en total nettodosis på 900 IE rekombinant follikelstimulerende hormon (FSH) i 1,08 ml vandig opløsning.
English: Puregon 150 IU/0.5 mL solution for injection EU/1/96/008/026
Danish: Puregon 150 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/026
English: Puregon 50 IU/0.5 mL solution for injection EU/1/96/008/017
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning EU/1/96/008/017
English: VIAL TEXT Puregon 150 IU/0.5 mL
Danish: HÆTTEGLAS TEKST Puregon 150 IE/0,5 ml
English: Puregon 150 IU/0.5 mL solution for injection
Danish: Puregon 150 IE/0,5 ml injektionsvæske, opløsning
English: OUTER CARTON TEXT Puregon 150 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 150 IE/0,5 ml 1, 5 eller 10 hætteglas
English: One vial contains 22.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 22,5 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: Puregon 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 150 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 150 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: One vial contains 7.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 7,5 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: Puregon 200 IU/0.5 mL solution for injection
Danish: Puregon 200 IE/0,5 ml injektionsvæske, opløsning
English: Puregon 50 IU/0.5 mL solution for injection
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning
English: For use only with the Puregon Pen.
Danish: Subkutan (s.c.) anvendelse Må kun anvendes i Puregon Pen.
English: OUTER CARTON TEXT Puregon 200 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 200 IE/0,5 ml 1, 5 eller 10 hætteglas
English: Puregon 100 IU/0.5 mL solution for injection
Danish: Puregon 100 IE/0,5 ml injektionsvæske, opløsning
English: Puregon 200 IU/0.5 mL injection follitropin beta
Danish: Puregon 200 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: 1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Puregon 900 IE/1,08 ml injektionsvæske, opløsning 1,08 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: Puregon 50 IU/0.5 mL injection follitropin beta
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Puregon 300 IU/0.36 mL solution for injection follitropin beta
Danish: Puregon 300 IE/0,36 ml injektionsvæske, opløsning follitropin beta
English: Puregon 200 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 200 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 200 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 200 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: OUTER CARTON TEXT Puregon 50 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 50 IE/0,5 ml 1, 5 eller 10 hætteglas
English: One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 mL aqueous solution.
Danish: Puregon 300 IE/0,36 ml injektionsvæske, opløsning En cylinderampul indeholder en total nettodosis på 300 IE rekombinant follikelstimulerende hormon (FSH) i 0,36 ml vandig opløsning.
English: Puregon 150 IU/0.5 mL injection follitropin beta
Danish: Puregon 150 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: 0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Puregon 300 IE/0,36 ml injektionsvæske, opløsning 0,36 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: Puregon 100 IU/0.5 mL injection follitropin beta
Danish: Puregon 100 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: OUTER CARTON TEXT Puregon 100 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Puregon 100 IE/0,5 ml 1, 5 eller 10 hætteglas
English: Do not mix any other drug into the cartridges.Empty cartridges must not be refilled.
Danish: Bland ikke andre stoffer i cylinderampullen.
English: Puregon 50 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 50 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 50 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: 0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Puregon 600 IE/0,72 ml injektionsvæske, opløsning 0,72 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: Puregon 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous solution per vial.
Danish: Puregon 100 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 100 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: Puregon 900 IU/1.08 mL solution for injection follitropin beta
Danish: Puregon 900 IE/1,08 ml injektionsvæske, opløsning follitropin beta
English: 0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning 0,18 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: One cartridge contains a net total dose of 600 IU recombinant follicle-stimulating hormone (FSH) in 0.72 mL aqueous solution.
Danish: Puregon 600 IE/0,72 ml injektionsvæske, opløsning En cylinderampul indeholder en total nettodosis på 600 IE rekombinant follikelstimulerende hormon (FSH) i 0,72 ml vandig opløsning.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke Puregon efter den udløbsdato, som står på etiketten på yderkartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: PC:
Danish: (PCOS).
English: Puregon 600 IU/0.72 mL solution for injection follitropin beta
Danish: Puregon 600 IE/0,72 ml injektionsvæske, opløsning follitropin beta
English: One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in 0.18 mL aqueous solution.
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning En cylinderampul indeholder en total nettodosis på 150 IE rekombinant follikelstimulerende hormon (FSH) i 0,18 ml vandig opløsning.
English: For males and females
Danish: Mænd og kvinder
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Puregon can bring about the development of multiple follicles.
Danish: Puregon kan fremkalde udvikling af mange follikler hos kvinder, som gennemgår reproduktionsbehandling (kunstig befrugtning), inklusive reagensglasbefrugtning (in vitro fertilisation (IVF)) eller andre behandlinger.
English: Puregon 150 IU/0.18 mL solution for injection follitropin beta
Danish: Puregon 150 IE/0,18 ml injektionsvæske, opløsning follitropin beta
English: ‘Essential' means that no specific cause for the hypertension can be found.
Danish: "Essentiel" betyder, at der ikke kan findes en bestemt årsag til hypertensionen.
English: Further information on Rasilez HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Rasilez HCT findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Rasilez HCT received a marketing authorisation valid throughout the EU on 16 January 2009.
Danish: Rasilez HCT fik en markedsføringstilladelse med gyldighed i hele EU den 16. januar 2009.
English: Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Danish: Sammenlagt har virksomheden fremlagt resultater fra ni hovedstudier med deltagelse af næsten 9 000 patienter med essentiel hypertension.
English: Rasilez HCT can only be obtained with a prescription and it is available as tablets (150 mg/12.5 mg; 150 mg/25 mg; 300 mg /12.5 mg; 300 mg/25 mg).The recommended dose of Rasilez HCT is one tablet per day.
Danish: Rasilez HCT udleveres kun efter recept, og det fås som tabletter (150 mg/12,5 mg, 150 mg/25 mg, 300 mg/12,5 mg og 300 mg/25 mg).Den anbefalede dosis af Rasilez HCT er én tablet dagligt.
English: Aliskiren on its own has been authorised in the EU since August 2007 as Rasilez, Sprimeo and Riprazo.
Danish: Enkeltstofbehandling med Aliskiren har været godkendt i EU siden august 2007 som Rasilez, Sprimeo og Riprazo.
English: Side effects are similar to those of the two active substances.
Danish: Bivirkningerne er de samme som for de to aktive stoffer.
English: The company presented information used in the assessment of aliskiren and from the published literature to support its application for Rasilez HCT, as well as information from additional studies.
Danish: Virksomheden fremlagde oplysninger, som blev anvendt i vurderingen af aliskiren, og fra den offentliggjorte dokumentation til støtte for sin ansøgning for Rasilez HCT samt oplysninger fra yderligere studier.
English: Taking the two active substances in one tablet is expected to help patients to stick to their treatment.
Danish: Det forventes, at kombinationen af de to aktive stoffer i én tablet vil hjælpe patienterne med at overholde deres behandling.
English: The most common side effect with Rasilez HCT (which may affect between 1 and 10 patients in 100) is diarrhoea.
Danish: Den hyppigste bivirkning ved Rasilez HCT (som kan forekomme hos mellem 1 og 10 patienter ud af 100) er diarré.
English: For more information about using Rasilez HCT, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Rasilez HCT, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Results showed that Rasilez HCT was more effective than placebo in reducing blood pressure.
Danish: Resultaterne viste, at Rasilez HCT var mere effektivt end placebo til at mindske blodtrykket.
English: After two to four weeks of taking Rasilez HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.
Danish: Efter at have taget Rasilez HCT i to til fire uger kan dosen øges hos patienter, hvis blodtryk fortsat ikke er under kontrol.
English: Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Danish: De fleste studier omfattede patienter med mild til moderat hypertension, og ét studie omfattede patienter med svær hypertension.
English: Three additional studies showed that the active substances were absorbed in the body in the same way when taken as separate tablets and as Rasilez HCT.
Danish: Tre ekstra studier viste, at de aktive stoffer blev optaget i kroppen på samme måde, når de blev taget som særskilte tabletter og som Rasilez HCT.
English: As for all medicines, data on the use of Rasilez HCT are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Rasilez HCT løbende overvåget.
English: Side effects reported with Rasilez HCT are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Rasilez HCT vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Other information about Rasilez HCT
Danish: Andre oplysninger om Rasilez HCT
English: Rasilez HCT (aliskiren / hydrochlorothiazide)
Danish: Rasilez HCT (aliskiren/hydrochlorthiazid)
English: Rasilez HCT should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Danish: Rasilez HCT må ikke tages sammen med frugtsaft eller drikkevarer, som indeholder planteekstrakter som f.eks. urtete.