FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who first initiated Spinraza treatment in Study CS11 (n=24; sham control in Study CS3B) were of a median age of 17.8 months (range 10 - 23 months) and had a mean CHOP INTEND score of 17.25 (range 2.0 - 46.0) at baseline in Study CS11.
Danish: De patienter, der først startede behandling med Spinraza i studie CS11 (n=24; sham-kontrol i studie CS3B), havde en medianalder på 17,8 måneder (interval 10-23 måneder) samt en gennemsnitlig CHOP INTEND-score på 17,25 (interval 2,0-46,0) ved baseline i studie CS11.
English: There is a risk of adverse reactions occurring as part of the lumbar puncture procedure (e.g. headache, back pain, vomiting; see section 4.8).
Danish: Der er en risiko for forekomst af bivirkninger i forbindelse med lumbalpunkturproceduren (f.eks. hovedpine, rygsmerter, opkastning, se pkt.
English: The population PK analysis suggests that race is unlikely to affect the PK of nusinersen.
Danish: Den populationsfarmakokinetiske analyse tyder på, at racen ikke påvirker farmakokinetikken for nusinersen.
English: Just prior to administration, remove the plastic cap and insert the syringe needle into the vial through the centre of the over-seal to remove the appropriate volume.
Danish: Plasticlåget fjernes umiddelbart før administration, og kanylen på sprøjten indføres i hætteglasset gennem midten af overforseglingen for at udtage det relevante volumen.
English: Other medicines and Spinraza
Danish: Brug af anden medicin sammen med Spinraza
English: Patients in this study were deemed most likely to develop Type II or III SMA.
Danish: Patienterne i dette studie blev vurderet til at have størst sandsynlighed for at udvikle type II- eller III-SMA.
English: At day 700, 7 out of 11 patients (64%) with 2 SMN2 gene copies and 0 out of 5 patients (0%) with 3 SMN2 copies, met the protocol-defined criteria of clinically manifested SMA, however, these patients were gaining weight and achieving WHO milestones, inconsistent with Type I SMA.
Danish: Ved dag 700 opfyldte 7 ud af 11 patienter (64 %) med 2 SMN2-genkopier og 0 ud af 5 patienter (0 %) med 3 SMN2-kopier de protokoldefinerede kriterier for klinisk manifestation af SMA.
English: If you have any questions about how Spinraza is given, ask your doctor.
Danish: Spørg lægen, hvis der er noget du er i tvivl om med hensyn til, hvordan Spinraza gives.
English: Further improvement in mean total motor milestone (HINE-Section 2) (2.1; SD 4.36; n=22) and CHOP INTEND (4.68; SD 3.993, n=22) scores were observed from baseline to Study Day 304 in Study CS11.
Danish: Yderligere forbedring i gennemsnitlige totale motoriske milepæl-scorer (HINE afsnit 2) (2,1; SD 4,36; n=22) og CHOP INTEND (4,68; SD 3,993, n=22) blev observeret fra baseline til dag 304 i studie CS11.
English: Spinraza has not been studied in patients with renal impairment.
Danish: Spinraza er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: Patients in this study were deemed most likely to develop Type I SMA.
Danish: Patienterne i dette studie blev vurderet til at have størst sandsynlighed for at udvikle type 1-SMA.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.
Danish: Natriumdihydrogenphosphatdihydrat, dinatriumphosphat, natriumchlorid, kaliumchlorid, calciumchloriddihydrat, magnesiumchloridhexahydrat, natriumhydroxid, saltsyre, vand til injektionsvæsker.
English: The mean 6MWT distance was 278.5 meters (SD 206.46) at Day 253 and 333.6 metres (SD 176.47) at Day 1050.
Danish: Den gennemsnitlige 6MWT-afstand var 278,5 meter (SD 206,46) på dag 253 og 333,6 meter (SD 176,47) på dag 1050.
English: Each ml contains 2.4 mg of nusinersen.
Danish: Hver ml indeholder 2,4 mg nusinersen.
English: Not known (cannot be estimated from the available data) Table 1: Adverse reactions related to lumbar puncture procedure reported in CS4 (later onset SMA) with an incidence at least 5% higher in patients treated with Spinraza than sham-control
Danish: Tabel 1: Bivirkninger i forbindelse med lumbalpunkturproceduren indberettet i CS4 (senere debut af SMA) med en forekomst, der er mindst 5 % højere hos patienter behandlet med Spinraza versus sham-kontrol
English: In these patients, a mean improvement of 28.6 meters (SD 47.22, n=12) at Day 253 and 86.5 metres (SD 40.58, n=8) at Day 1050.
Danish: Hos disse patienter blev der observeret en gennemsnitlig forbedring på 28,6 meter (SD 47,22, n=12) på dag 253 og 86,5 meter (SD 40,58, n=8) på dag 1050.
English: Initiation of treatment sooner after symptom onset resulted in earlier and greater improvement in motor function than those with delayed treatment initiation; however, both groups experienced benefit compared to sham-control.
Danish: En hurtigere behandlingsstart efter symptomdebut førte til tidligere og større forbedringer i motorisk funktion end for personer med en senere behandlingsstart.
English: Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Danish: For disse patienter blev der observeret stabilisering eller forbedring i gennemsnitlig HFMSE-score (1,4; SD 4,02) og RULM-score (2,1; SD 2,56) fra baseline til dag 265 i studie CS11.
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen (2.4 mg/ml).
Danish: Hvert 5 ml hætteglas indeholder nusinersennatrium svarende til 12 mg nusinersen (2,4 mg/ml)
English: At the final analysis, a statistically significant greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (51%) compared to the sham-control group (0%) (p<0.0001).
Danish: Ved den endelige analyse opnåede en statistisk signifikant større procentdel af patienter definitionen på motorisk milepæl-respons i Spinraza-gruppen (51 %) sammenlignet med sham-kontrolgruppen
English: - Each ml contains 2.4 mg of nusinersen.
Danish: - Hver ml indeholder 2,4 mg nusinersen.
English: Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Calciumchloriddihydrat Magnesiumchloridhexahydrat Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering) Vand til injektionsvæsker
English: Statistically significant effects on event-free survival, overall survival, the proportion of patients achieving the definition of a motor milestone responder, and the percentage of patients with at least a 4-point improvement from baseline in Children's Hospital of Philadelphia
Danish: Statistisk signifikante virkninger på hændelsesfri overlevelse, samlet overlevelse, andelen af patienter, der opnåede definitionen på motorisk milepæl-respons, og procentdelen af patienter med en forbedring på mindst 4 point fra baseline i Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND)-score blev observeret hos patienter i Spinraza-gruppen sammenlignet med patienter i sham-kontrolgruppen (tabel 2).
English: Spinraza 12 mg solution for injection nusinersen
Danish: Spinraza 12 mg injektionsvæske, opløsning nusinersen
English: If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C.
Danish: Hvis Spinraza tages ud af den originale yderkarton, bør den totale, kombinerede tid ude af køleskabet ikke overskride 30 timer ved en temperatur, der ikke overskrider 25 °C.
English: All patients who received Spinraza were alive as of the early termination of Part 1, however, one patient in the control arm died at Study Day 289.
Danish: Alle de patienter, der fik Spinraza, var i live ved den tidlige afslutning af del 1.
English: In patients with Type II SMA the Upper Limb Module test was conducted with mean improvement of 1.9 (SD 2.68, n=11) at Day 253 and 3.5 (SD 3.32, n=9) at Day 1050.
Danish: Hos patienter med Type II SMA blev Upper Limb Module-testen udført med en gennemsnitlig forbedring på 1,9 (SD 2,68, n=11) på dag 253 og 3,5 (SD 3,32, n=9) på dag 1050.
English: Patients in this study were deemed most likely to develop Type I or II SMA.
Danish: Patienterne i dette studie blev vurderet til at have størst sandsynlighed for at udvikle type I eller II SMA.
English: A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Danish: Der blev observeret en vedvarende forbedring hos patienter med type II SMA, som havde en gennemsnitlig forbedring fra baseline i HFMSE-score på 5,1 (SD 4,05, n=11) på dag 253 og 9,1(SD 6,61, n=9) på dag 1050.
English: Talk to your doctor before you or your child are given Spinraza.
Danish: Kontakt lægen, før du eller dit barn får Spinraza.
English: Study CS3B (ENDEAR) was a Phase 3, randomized, double-blind, sham-procedure controlled study conducted in 121 symptomatic infants ≤ 7 months of age, diagnosed with SMA (symptom onset before 6 months of age).
Danish: Studie CS3B (ENDEAR) var et fase 3, randomiseret, dobbeltblindet studie med sham (imiteret) kontrol, der blev udført hos 121 symptomatiske spædbørn i alderen ≤ 7 måneder med en SMAdiagnose (symptomdebut før 6-måneders-alderen).
English: What you need to know before you or your child are given Spinraza 3.
Danish: Det skal du vide, før du eller dit barn begynder at få Spinraza 3.
English: Improvement in mean total motor milestone (HINE-Section 2) (1.2; SD 1.8; n=12) and CHOP INTEND (3.58; SD 7.051, n=12) scores were observed from baseline to Study Day 304 in Study CS11.
Danish: Der blev observeret forbedring i gennemsnitlige totale motoriske milepæl-scorer (HINE afsnit 2) (1,2; SD 1,8; n=12) og CHOP INTEND (3,58; SD 7,051, n=12) fra baseline til dag 304 i studie CS11.
English: Of patients who initiated Spinraza treatment in Study CS4 (n=39), stabilization or additional improvements in mean HFMSE (0.2; SD 3.06) and RULM (0.7; SD 2.69) scores were observed from baseline to Study Day 265 in Study CS11.
Danish: For de patienter, der startede på behandling med Spinraza i studie CS4 (n=39), blev der observeret stabilisering eller yderligere forbedringer i gennemsnitlig HFMSE-score (0,2; SD 3,06) og RULMscore (0,7; SD 2,69) fra baseline til dag 265 i studie CS11.
English: How Spinraza is given
Danish: Sådan gives Spinraza
English: Study CS4 (CHERISH) was a Phase 3, randomised, double-blind, sham-procedure controlled study conducted in 126 symptomatic patients with later-onset SMA (symptom onset after 6 months of age).
Danish: Studie CS4 (CHERISH) var et fase 3, randomiseret, dobbeltblindet studie med sham-kontrol, der blev udført hos 125 symptomatiske patienter med en senere debut af SMA (symptomdebut efter 6-måneders-alderen).
English: The mean total score was 49.8 (SD 12.46) at Day 253 and 52.6 (SD 12.78) at 1050 days.
Danish: Den gennemsnitlige totale score var 49,8 (SD 12,46) på dag 253 og 52,6 (SD 12,78) på dag 1050.
English: Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050.
Danish: Patienter med type III SMA viste en gennemsnitlig forbedring fra baseline HFMSE-score på 1,3 (SD 1,87, n=16) på dag 253 og 1,2 (SD 4,64, n=11) på dag 1050.
English: The primary endpoint was the proportion of patients who improved in one or more categories in motor milestones (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick or voluntary grasp OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking).
Danish: Det primære endepunkt var andelen af patienter, der oplevede forbedring i en eller flere kategorier af motoriske milepæle (i henhold til HINE afsnit 2: ≥2 point forbedring [eller maksimal score] i evnen til
English: The mean total score was13.8 (SD 3.09) at Day 253 and 15.7 (SD 1.92) at Day 1050.
Danish: Den gennemsnitlige totale score var 13,8 (SD 3,09) på dag 253 og 15,7 (SD 1,92) på dag 1050.
English: България ТП ЕВОФАРМА
Danish: ТП ЕВОФАРМА Teл.
English: Gastrointestinal disorders
Danish: Spinraza Kontrol
English: As a precautionary measure, it is preferable to avoid the use of Spinraza during pregnancy.
Danish: For en sikkerheds skyld bør Spinraza undgås under graviditeten.
English: 1CS4 was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significant improvement from baseline HFMSE score was observed in Spinraza treated patients compared to the sham-control patients (Spinraza vs. sham-control: 4.0 vs. -1.9; p=0.0000002))
Danish: 1CS4 blev stoppet efter en positiv statistisk analyse af det primære endepunkt ved interimanalysen (statistisk signifikant forbedring fra baseline-HFMSE-score blev observeret hos Spinraza-behandlede patienter sammenlignet med sham-kontrolpatienterne (Spinraza vs. sham-kontrol: 4,0 vs. -1,9; p=0,0000002)) 2Vurderet ved hjælp af Intent to Treat-populationen (Spinraza n=84; Sham-kontrol n=42); data for patienter uden et besøg ved måned 15 blev beregnet ved hjælp af den multiple imputeringsmetode 3Mindste kvadraters gennemsnit
English: The assessment of undesirable effects is based on the following frequency data:
Danish: Vurderingen af bivirkninger er baseret på følgende hyppighedsdata: Meget almindelig (≥ 1/10)
English: 4Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 5According to Hammersmith Infant Neurological Examination (HINE) section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening, defined as a responder for this primary analysis.
Danish: 2: ≥2 point forbedring [eller maksimal score] i evne til at sparke, ELLER ≥1 point forbedring i de motoriske milepæle hovedkontrol, rulle, sidde, kravle, stå eller gå OG forbedring i flere kategorier af motoriske milepæle end forværring, defineret som respons i denne primære analyse.
English: Infantile onset
Danish: Debut i spædbarnsalderen
English: Sedation may be required to administer Spinraza, as indicated by the clinical condition of the patient.
Danish: Det kan være nødvendigt at bedøve for at administrere Spinraza.
English: The mean total score was 26.4 (SD 11.91) at Day 253 and 31.3 (SD 13.02) at Day 1050, no plateau was observed.
Danish: Den gennemsnitlige totale score var 26,4 (SD 11,91) på dag 253 og 31,3 (SD 13,02) på dag 1050.
English: - Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Danish: - Hvert 5 ml hætteglas indeholder nusinersennatrium svarende til 12 mg nusinersen.
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Danish: Hvert 5 ml hætteglas indeholder nusinersennatrium svarende til 12 mg nusinersen.
English: 1CS3B was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significantly greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (41%) compared to the sham-control group (0%), p<0.0001) 2At the final analysis, event-free survival and overall survival were assessed using the Intent to Treat population (ITT Spinraza n=80; Sham-control n=41).
Danish: 1CS3B blev stoppet efter en positiv statistisk analyse af det primære endepunkt ved interimanalysen (statistisk signifikant større procentdel af patienter, der opnåede definitionen på et motorisk milepæl-respons i Spinraza-gruppen (41 %), sammenlignet med sham-kontrolgruppen (0 %), p<0,0001).
English: Proportion with improvement in total motor milestone score Proportion with worsening in total motor milestone score p<0.0001
Danish: Andel ved dag 1837 Andel ved dag 3027 Andel ved dag 3947 Andel med forbedring i total motorisk milepæl-score Andel med forværring i total motorisk milepæl-score
English: Spinraza is given by injection into the lower back.
Danish: Spinraza gives som en injektion i lænden.
English: Spinraza 12 mg solution for injection
Danish: Spinraza 12 mg injektionsvæske, opløsning.
English: Each dose of Spinraza contains less than 1 mmol (23 mg) sodium.
Danish: Spinraza indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri og kan anvendes til patienter på en natriumbegrænset diæt.
English: CS7 is a phase 2, randomized, double-blind, sham-procedure study in symptomatic patients diagnosed with infantileonset SMA (≤6 months) or later-onset SMA (>6 months) and 2 or 3 copies of SMN2 (Part 1), followed by a long-term open label extension phase (Part 2).
Danish: eller senere debut af SMA (>6 måneder) samt 2 eller 3 kopier af SMN2 (del 1), efterfulgt af en længerevarende åben forlængelsesfase (del 2).
English: Spinraza is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment (see sections 4.5 and 5.2).
Danish: Spinraza metaboliseres ikke af CYP450-enzymsystemet i leveren.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
Danish: - Øvrige indholdsstoffer: natriumdihydrogenphosphatdihydrat, dinatriumphosphat,
English: Spinraza is given;
Danish: Spinraza gives:
English: • If you or your child gets any side effects, talk to your doctor or nurse.
Danish: • Kontakt lægen eller sundhedspersonalet, hvis du eller dit barn får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Aseptic technique should be used when preparing and administering Spinraza; see instructions for use in section 6.6.
Danish: Der bør anvendes aseptisk teknik under forberedelse og administration af Spinraza.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate Sodium chloride
Danish: Natriumdihydrogenphosphatdihydrat Dinatriumphosphat Natriumchlorid
English: Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 2, open-label study (NURTURE (SM201))
Danish: Fremsendelse af med spinal muskalatrofi skal indehaveren af markedsføringstilladelsen gennemføre og fremsende resultaterne af det åbne fase 2-studie (SM201)
English: Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Gefitinib Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The tablet can be dispersed in water for patients who have difficulty swallowing.
Danish: Tabletten kan opløses i vand, hvis patienten har vanskeligt ved at synke.
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Danish: Det anvendes hos patienter, hvis kræftceller har en mutation i de gener, der laver proteinet epidermal vækstfaktor-receptor (EGFR).
English: EGFR is involved in the growth and spread of cancer cells.
Danish: EGFR medvirker til vækst og spredning af kræftceller.
English: For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Gefitinib Mylan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.
Danish: Gefitinib Mylan udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i kræftbehandling.
English: Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Gefitinib Mylan vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Gefitinib Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Gefitinib Mylan er af sammenlignelig kvalitet og er bioækvivalent med Iressa.
English: As for all medicines, data on the use of Gefitinib Mylan are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Gefitinib Mylan løbende overvåget.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Danish: Der er allerede gennemført studier af det aktive stofs fordele og risici i den godkendte anvendelse af referencelægemidlet, Iressa, og de behøver ikke at blive gentaget for Gefitinib Mylan.
English: An overview of Gefitinib Mylan and why it is authorised in the EU
Danish: En oversigt over Gefitinib Mylan, og hvorfor det er godkendt i EU
English: As for every medicine, the company provided studies on the quality of Gefitinib Mylan.
Danish: Som for alle lægemidler har firmaet leveret studier vedrørende kvaliteten af Gefitinib Mylan.
English: Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Danish: Gefitinib Mylan er et kræftlægemiddel til behandling af voksne med ikke-småcellet lungekræft, der er lokalt fremskreden eller metastatisk (når kræftcellerne har spredt sig fra lungerne til andre dele af kroppen).
English: Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Danish: Gefitinib Mylan fås som tabletter a 250 mg, der tages gennem munden.
English: This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
Danish: Det betyder, at Gefitinib Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Iressa.
English: What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Gefitinib Mylan?
English: What is Gefitinib Mylan and what is it used for?
Danish: Hvad er Gefitinib Mylan, og hvad anvendes det til?
English: Other information about Gefitinib Mylan
Danish: Andre oplysninger om Gefitinib Mylan
English: What are the benefits and risks of Gefitinib Mylan?
Danish: Hvilke fordele og risici er der forbundet med Gefitinib Mylan?
English: By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer.
Danish: Ved at blokere EGFR er Gefitinib Mylan med til at bremse kræftens vækst og spredning.
English: Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Danish: Gefitinib Mylan virker kun i de kræftceller ved ikke-småcellet lungekræft, der har en mutation i deres EGFR.
English: This means that it blocks specific enzymes known as tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer enzymer af typen tyrosinkinaser.
English: The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor.
Danish: Det aktive stof i Gefitinib Mylan, gefitinib, er en såkaldt protein-tyrosinkinasehæmmer.