FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
Danish: LÆGEMIDLETS NAVN GONAL-f 300 IE/0,5 ml (22 mikrogram/0,5 ml) injektionsvæske, opløsning i fyldt pen
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in pre-filled pen.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) GONAL-f 300 IE/0,5 ml (22 mikrogram/0,5 ml) injektionsvæske, opløsning i fyldt pen Follitropin alfa.
English: After reconstitution, do not store above 25°C.
Danish: Når medicinen er rekonstitueret, må den ikke opbevares ved temperaturer over 25 °C.
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) pulver og solvens til injektionsvæske, opløsning
English: GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Danish: GONAL-f 300 IE/0,5 ml (22 mikrogram/0,5 ml) injektionsvæske, opløsning i fyldt pen Follitropin alfa
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection Follitropin alfa
Danish: GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) pulver og solvens til injektionsvæske, opløsning Follitropin alfa
English: 1.5 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Danish: 1,5 ml injektionsvæske, opløsning i 3 ml cylinderampul (type I glas), med en stempelprop (halobutylgummi) og en aluminium beskyttelseshætte med gummiindlæg.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Danish: GONAL-f 1.050 IE/1,75 ml (77 mikrogram/1,75 ml) opløsning må ikke blandes med andre beholdere med GONAL-f i samme hætteglas eller injektionssprøjte.
English: Contents
Danish: Gevindspids
English: If you use more GONAL-f than you should
Danish: Hvis du har brugt for meget GONAL-f
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/0.75 ML (33 MICROGRAMS/0.75 ML), VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER GONAL-f 450 IE/0,75 ML (33 MIKROGRAM/0,75 ML), ETIKET TIL HÆTTEGLAS
English: Look closely at the tip of the needle for tiny drop(s) of fluid
Danish: Inspicer kanylespidsen nøje for bittesmå dråber væske
English: Contains: One pre-filled syringe of solvent contains: 0.75 mL water for injections, benzyl alcohol
Danish: Indeholder: En fyldt injektionssprøjte med solvens indeholder: 0,75 ml vand til injektionsvæsker, benzylalkohol 0,9%.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Danish: GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) opløsning må ikke blandes med andre beholdere med GONAL-f i samme hætteglas eller injektionssprøjte.
English: Storing the GONAL-f pre-filled pen.
Danish: 7.4 Opbevaring af GONAL-f fyldt pen
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 GONAL-f 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 GONAL-f-injektion.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 mL.
Danish: • Solvensen er en farveløs væske i en fyldt injektionssprøjte; hver fyldte injektionssprøjte indeholder 2 ml.
English: if "0", injection complete ifnot"0",needsecond injection Inject this amount ..........using new pen
Danish: hvis ”0” er injektionen gennemført hvisikke ”0” er det nødvendigt med en til injektion Injicer denne mængde ..........med en ny pen
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/95/001/021
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml), injektionsvæske, opløsning i fyldt pen Follitropin alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/034 solution for injection in pre-filled pen.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/034 injektionsvæske, opløsning i fyldt pen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/035 solution for injection in pre-filled pen.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/035 Injektionsvæske, opløsning i fyldt pen.
English: Each multidose vial contains 87 micrograms follitropin alfa equivalent to 1200 IU.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert flerdosis hætteglas indeholder 87 mikrogram follitropin alfa, svarende til 1.200 IE. Hver ml rekonstitueret opløsning indeholder 600 IE.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Danish: GONAL-f 300 IE/0,50 ml (22 mikrogram/0,50 ml) opløsning må ikke blandes med andre beholdere med GONAL-f i samme hætteglas eller injektionssprøjte.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection.
Danish: GONAL-f 1.050 IE/1,75 ml (77 mikrogram/1,75 ml) pulver og solvens til injektionsvæske Follitropin alfa.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 mL.
Danish: • Solvensen er en farveløs væske i en fyldt injektionssprøjte; hver fyldte injektionssprøjte indeholder 1 ml.
English: Dose Feedback Window 6.
Danish: Skærm med dosisfeedback
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/033 solution for injection in pre-filled pen.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/033 Injektionsvæske, opløsning i fyldt pen.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/033
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/95/001/033
English: 1 pre-filled syringe of solvent.
Danish: 1 fyldt injektionssprøjte med solvens.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen Follitropin alfa
Danish: GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) injektionsvæske, opløsning i fyldt pen Follitropin alfa
English: NAME OF THE MEDICINAL PRODUCT GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
Danish: LÆGEMIDLETS NAVN GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) injektionsvæske, opløsning i fyldt pen
English: Warning: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Danish: Advarsel: Skru ikke kanylen for stramt på.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/034
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/95/001/034
English: Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the tip of the needle.
Danish: En lillebitte dråbe væske vil vise sig ved kanylespidsen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/005 1 vial of powder for solution for injection.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/005 1 hætteglas med pulver til injektionsvæske, opløsning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/032 1 vial of powder for solution for injection.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/032 1 hætteglas med pulver til injektionsvæske, opløsning.
English: 1 pre-filled syringe of 1 mL solvent.
Danish: 1 fyldt injektionssprøjte med 1 ml solvens.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/031
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/95/001/031
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/035
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/95/001/035
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/021 1 vial of powder for solution for injection.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/021 1 hætteglas med pulver til injektionsvæske, opløsning.
English: 1 vial of powder for solution for injection.
Danish: 1 hætteglas med pulver til injektionsvæske, opløsning.
English: Each multidose vial contains 44 micrograms follitropin alfa* equivalent to 600 IU.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert flerdosis hætteglas indeholder 44 mikrogram follitropin alfa*, svarende til 600 IE. Hver ml rekonstitueret opløsning indeholder 600 IE.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/031 1 vial of powder for solution for injection.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/95/001/031 1 hætteglas med pulver til injektionsvæske, opløsning.
English: Each vial contains 5.5 micrograms follitropin alfa equivalent to 75 IU.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 5,5 mikrogram follitropin alfa, svarende til 75 IE. Hver ml rekonstitueret opløsning indeholder 75 IE.
English: if"0", injectioncomplete if not "0", need second injection Inject this amount ..........using newpen
Danish: hvis ”0” er injektionen gennemført hvis ikke ”0” er det nødvendigt med en til injektion Injicer denne mængde ..........med en ny pen
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection.
Danish: GONAL-f 300 IE/0,50 ml (22 mikrogram/0,50 ml) pulver og solvens til injektionsvæske, opløsning Follitropin alfa.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection.
Danish: GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) pulver og solvens til injektionsvæske, opløsning Follitropin alfa.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in pre-filled pen.
Danish: GONAL-f 450 IE/0,75 ml (33 mikrogram/0,75 ml) injektionsvæske, opløsning i fyldt pen Follitropin alfa.
English: Alcohol swabs
Danish: Spritservietter
English: Each multidose vial contains 33 micrograms follitropin alfa equivalent to 450 IU.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert flerdosis hætteglas indeholder 33 mikrogram follitropin alfa, svarende til 450 IE. Hver ml rekonstitueret opløsning indeholder 600 IE.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GONAL-f 1050 IU/1.75 mL powder for solution for injection.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) GONAL-f 1.050 IE/1,75 ml, pulver til injektionsvæske, opløsning Follitropin alfa s.c.
English: Batch
Danish: Penhætte
English: • Hold the outer needle cap firmly.
Danish: • Hold godt fast om den ydre kanylehætte.
English: Common:
Danish: Eksempel:
English: Date of first authorisation: 21 February 2008 Date of first renewal: 19 November 2012
Danish: Dato for første markedsføringstilladelse: 21, februar, 2008 Dato for seneste fornyelse: 19. november 2012
English: However, MPA Cmax was decreased by 40% in the presence of food.
Danish: MPA Cmax var dog nedsat med 40 % i nærvær af føde.
English: These changes are not associated with impaired neutrophil function.
Danish: Ændringerne er ikke associerede med en svækket neutrophil funktion.
English: Hepatic transplant patients were followed for at least 1°year, but less than 3°years.
Danish: Levertransplanterede patienter fulgtes i mindst 1 år, men i mindre 3 år.
English: • You are a child or teenager who has not started having periods.
Danish: • Du er barn eller teenager, og endnu ikke har fået menstruation.
English: EU/1/07/439/003 (50 tablets) EU/1/07/439/004 (150 tablets) EU/1/07/439/005 (50 x 1 tablets)
Danish: EU/07/1/439/003 (50 tabletter) EU/07/1/439/004 (150 tabletter) EU/1/07/439/005 (50x1 tabletter)
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Danish: Det bør derfor undgås til patienter med sjældne arvelig mangel på hypoxantin-guanin-fosforibosyltransferase (HGPRT) såsom Lesch-Nyhan og Kelley-Seegmiller syndrom.
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Danish: MPA er en potent, selektiv, ikke-kompetitiv og reversibel inhibitor af inosin-monophosfat-dehydrogenase og hæmmer derfor de novo-vejen for en guanosin-nucleotid- syntese uden inkorporering i DNA.
English: In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Danish: I de tilfælde af overdosering, hvor der var bivirkninger, fandtes disse at være indenfor den kendte sikkerhedsprofil for lægemidlet.
English: Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Danish: Andre bivirkninger, som er indberettet efter markedsføringen beskrives nedenfor, med frekvenserne angivet i parentes, hvis de er kendt.
English: EU/1/07/439/001 (100 capsules) EU/1/07/439/002 (300 capsules) EU/1/07/439/006 (100 x 1 capsules)
Danish: EU/1/07/439/001 (100 kapsler) EU/1/07/439/002 (300 kapsler) EU/1/07/439/006 (100x1 kapsler)
English: • if you have or ever have had any problems with your digestive system, e.g. stomach ulcers.
Danish: - Hvis du har eller nogensinde har haft problemer med dit fordøjelsessystem, feks.
English: Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Danish: Serumnivauet af luteiniserende hormon (LH), folikelstimulenrende hormon (FSH) og progesteron blev ikke signifikant påvirket.
English: The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelsen og de nationale myndigheder skal være enige om indholdet og formen af uddannelsesprogrammet og et opfølgende spørgeskema ved graviditet, herunder også kommunikationsplaner, distributionsmetoder og alle andre aspekter af programmet.
English: The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with
Danish: Uddannelsesprogrammets formål er at sikre, at sundhedspersonale og patienter er bevidste om teratogeniciteten og mutageniciteten, nødvendigheden af graviditetstests før behandlingen med
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Danish: Ændringerne i MPAGs (MPAs fenoliske glukuronid) farmakokinetik (MPAG steg med 8 %) var minimale og anses ikke for klinisk signifikante.
English: Patients taking Mycophenolate mofetil Teva should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Danish: Patienter på Mycophenolate mofetil Teva bør have foretaget fuldstændig blodtælling hver uge den første måned, to gange om måneden den anden og tredje behandlingsmåned og derefter en gang om måneden igennem det første år.
English: If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Danish: Hvis du får pulver fra en itugået kapsel, i øjnene eller i munden, skal du skylle grundigt med rigeligt, frisk vand.
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Danish: Ældre patienter (≥65 år) har i almindelighed større risiko for bivirkninger pga. immunsuppresion.
English: The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Danish: De hæmopoietiske og lymfoide organsystemer var de første primære organer der blev afficeret i de toksikologiske studier der blev foretaget med mycophenolatmofetil på rotter, mus, hunde og aber.
English: MPA at clinically relevant concentrations is 97% bound to plasma albumin.
Danish: Ved klinisk relevante koncentrationer er ca. 97 % af MPA bundet til plasmaalbumin.
English: It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Danish: Mycophenolate mofetil Teva bør imidlertid administreres mindst én time før eller tre timer efter indtagelsen af sevelamer for at minimere dets indvirkning på MPA-absorptionen.
English: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Danish: Andelen af patienter med CMV viræmi/syndrome var
English: If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
Danish: Hvis du kan svare ja til nogen af de følgende spørgsmål, skal du tale med din læge, før du begynder at tage Mycophenolate mofetil Teva:
English: • Congenital heart disease such as atrial and ventricular septal defects;
Danish: • medfødt hjertesygdom såsom atriale og ventrikulære septumdefekter;
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4°g TID), indicating that there is a significant amount of enterohepatic recirculation.
Danish: En reduktion af MPA AUC på ca. 40 % er associeret til den samtidige administration af colestyramin (4 g tre gange daglig), hvilket indikerer, at der er en betragtelig enterohepatisk recirkulation.
English: Pancytopenia, leukocytosis
Danish: Pancytopeni, leukocytose
English: Agranulocytosis (≥1/1000 to <1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Danish: Agranulocytose (≥ 1/1.000 til < 1/100) og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med Mycophenolate mofetil Teva (se pkt.
English: • if you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Danish: Hvis du ikke anvender sikker prævention (se ”Graviditet, prævention og amning”).
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Danish: MPA metaboliseres hovedsageligt af glucuronyltransferase (isoform UGT1A9) til et inaktivt phenolglucuronid af MPA (MPAG).
English: Gingival hyperplasia (≥1/100 to <1/10), colitis including cytomegalovirus colitis (≥1/100 to <1/10),
Danish: Gingival hyperplasi (≥ 1/100 til <1/10), colitis inklusive cytomegalovirus colitis (≥ 1/100 til < 1/10),
English: In the early post-transplant period (<°40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6°months post-transplant).
Danish: I den tidlige posttransplantationsperiode (< 40 dage efter transplantationen) var den gennemsnitlige MPA AUC hos nyre-, hjerte- og levertransplanterede patienter ca. 30 % lavere og Cmax ca. 40 % lavere sammenlignet med den sene posttransplantationsperiode (3-6 måneder efter transplantationen).
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Danish: Sådanne infektioner inkluderer latent viral reaktivering, såsom hepatitis B, eller hepatitis C-reaktivering og infektioner forårsaget af polyomavira (BK-virus associeret med nefropati, JC-virus associeret med progressiv multifokal leukoencefalopati PML).
English: Patients should be advised that during treatment with Mycophenolate mofetil Teva, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Danish: Patienterne skal underrettes om at under behandling med Mycophenolate mofetil Teva kan vaccinationer være mindre effektive og levende svækkede vacciner bør undgås (se pkt.
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Danish: • kortåndethed, hoste, som kan skyldes bronkiektasi (en tilstand, hvor bronkierne er abnormalt udvidede) eller lungefibrose (dannelse af arvæv i lungene).
English: It is recommended that the second test should be performed 8-10°days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Danish: Det anbefales, at test nummer 2 skal udføres 8-10°dage efter den første test. Ved modtagelse af transplantater fra afdøde donorer, kan det på grund af tidspunktet for tilgængeligheden af transplantationsorganet, ikke altid være muligt at udføre to tests 8-10 dage efter hinanden, inden behandlingen initieres.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Danish: Alle transplanterede patienter har forhøjet risiko for opportunistiske infektioner idet risikoen øges med stigende immunsuppresiv belastning (se pkt.
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90°days after you stop taking Mycophenolate mofetil Teva.
Danish: Som en sikkerhedsforanstaltning anbefales det, at du eller din kvindelige partner bruger pålidelig prævention under behandlingen og i 90 dage efter, at du er stoppet med at tage Mycophenolate mofetil Teva.
English: Before starting Mycophenolate mofetil Teva treatment, women of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Danish: Før Mycophenolate mofetil Teva-behandlingen initieres, skal kvinder i den fertile alder have to negative graviditetstests (serum eller urin) med en sensitivitet på mindst 25 mIE/ml for at udelukke en uønsket mycophenolat-eksponering til fosteret.
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Danish: Spontane aborter (frekvens på 45 % til 49 %) og medfødte misdannelser (estimeret frekvens på 23 % til 27 %) er blevet rapporteret efter mycophenolatmofetil-eksponering under graviditet.
English: Arthralgia
Danish: Arthralgi
English: Mycophenolate mofetil Teva should be administered with caution in patients with active serious digestive system disease.
Danish: Mycophenolate mofetil Teva bør administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
English: Mycophenolate mofetil Teva, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Mycophenolate mofetil Teva.
Danish: Mycophenolate mofetil Teva initieres, kravene til prævention for både mandlige og kvindelige patienter, og hvilke tiltag der skal initieres, hvis der opstår graviditet under behandling med Mycophenolate mofetil Teva.