FrancophonIA/ELRC3.0 huggingface dataset:
English: • Jaundice (yellowing of the skin and eyes), changes in blood tests of liver function • Dry skin, unusual hair texture, nail disorder, skin rash, skin darkening, altered shape of fingers,
Danish: • Tør hud, unormal hårstruktur, negleproblemer, hudkløe, mørkfarvning af huden, ændring af fingrenes form, læsioner i huden
English: No dose adjustment is necessary in patients with mild or moderate renal insufficiency (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med mild til moderat nyreinsufficiens (se pkt.
English: • Uncommon: affects 1 to 10 users in 1,000
Danish: • Ikke almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 1.000 patienter
English: When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Danish: Menopausale symptomer, virkninger på uterint væv og brystvæv samt kardiovaskulære fordele og ulemper bør tages i betragtning ved behandling af postmenopausale kvinder med Fablyn eller andre lægemidler, herunder østrogener (se pkt.
English: Therefore safety and efficacy have not been studied (see section 5.2).
Danish: Derfor er sikkerhed og effekt ikke undersøgt hos børn og unge under 18 år (se pkt.
English: Lactation
Danish: Knogleomsætning
English: To assess the effect of FABLYN on diagnostic uterine procedures (i.e., hysteroscopy, saline infused sonohysterogram, endometrial biopsy, polypectomy or dilation and curettage), an analysis was conducted on women without planned TVU surveillance (4,055 patients).
Danish: Antallet af hysterektomier i Fablyn-gruppen (27/2302 patienter, 1,2 %) og i placebogruppen (24/2309 patienter, 1,0 %) var ens. For at vurdere virkningen af Fablyn på diagnostiske uterine procedurer (dvs. hysteroskopi, sonohysterografi med saltvandsindsprøjtning, endometriebiopsi, polypektomi eller dilatation og curettage) blev der udført en undersøgelse af kvinder uden planlagt TVU-overvågning (4055 patienter).
English: • Cough, difficulty breathing, stuffy nose, runny nose
Danish: • Hoste, vejrtrækningsbesvær, tilstoppet næse, løbende næse
English: hypophosphataemia, increased appetite, tetany, type 2 diabetes mellitus Psychiatric disorders
Danish: 2 diabetes mellitus, øget appetit
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (7 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (7 filmovertrukne tabletter)
English: Based on the absence of clinically relevant effects of cholestyramine (anion exchange resin), fluconazole (CYP2C9 inhibitor), ketoconazole (CYP3A4/5 inhibitor) and paroxetine (CYP2D6 inhibitor) on lasofoxifene pharmacokinetics, other anion exchange resins and other inhibitors of these CYP isoforms are unlikely to produce clinically meaningful alterations in FABLYN exposure and no dose adjustments are required.
Danish: Følgende stoffer har ingen klinisk relevant indvirkning på lasofoxifens farmakokinetik: cholestyramin (anionbytter-resin), fluconazol (CYP2C9-inhibitor), ketoconazol (CYP3A4/5-inhibitor) og paroxetin (CYP2D6-inhibitor).
English: stomach ache
Danish: Tørre øjne
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets lasofoxifene
Danish: LÆGEMIDLETS NAVN FABLYN 500 mikrogram Filmovertrukne tabletter lasofoxifen
English: • Impaired vision, pain in eyes, itchy eyes, swollen eyelids, redness of the eyes, ear pain • Lip lesions, change of bowel habits, difficulty swallowing, mouth ulcer, heart burn, mouth pain,
Danish: • Læsion på læben, ændring i tarmfloraen, besvær med at synke, mundsår, halsbrand, smerter i munden, endetarmssmerter
English: FABLYN must not be taken during lactation (see section 4.3).
Danish: Fablyn må ikke anvendes til ammende kvinder (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (30 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (30 filmovertrukne tabletter)
English: Reduced fertility, and an increase in pre- and post-implantation loss leading to reduced litter size and prolonged gestation were observed in females treated at ≥0.01 mg/kg/day (below the level of systemic exposure in humans).
Danish: Hos hunner behandlet med ≥0.01 mg/kg/dag (under niveauet for systemisk eksponering hos mennesker) sås nedsat fertilitet og en stigning i præ- og post-implantationstab, hvilket førte til nedsat kuldstørrelse samt forlænget gestation.
English: Bile duct stone, cholecystitis, hepatitis, jaundice, liver disorder Skin and subcutaneous tissue disorders Common Hyperhidrosis
Danish: Sjælden: Galdegangssten, gulsot, hepatitis, kolecystitis, leversygdom Hud og subkutane væv
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: If you take more tablets than you should, tell your doctor or pharmacist.
Danish: Hvis De har taget for FABLYN Kontakt lægen eller apoteket, hvis De har taget flere tabletter, end lægen har foreskrevet.
English: You should talk to your doctor before stopping FABLYN.
Danish: Hvis De holder op med at tage FABLYN Kontakt lægen, hvis De ønsker at stoppe behandlingen med FABLYN.
English: Amnesia, dementia Alzheimer's type, dizziness postural, dysgeusia, epilepsy, hydrocephalus, hypogeusia, memory impairment, migraine, migraine with aura, motor neurone disease, nerve compression, paresis, presyncope, sciatica, vascular headache Eye disorders Uncommon: Dry eye Rare:
Danish: Brændende fornemmelse, cerebralt infarkt, hovedpine, uro i benene Sjælden: Alzheimers demens, amnesi, dysgeusi, epilepsi, hukommelsessvækkelse, hydrocephalus, hypogeusi, ischias, migræne, migræne med aura, motorneuronsygdom, nervekompression, parese, postural svimmelhed, præsynkope, vaskulær hovedpine
English: Aphakia, chorioretinopathy, conjunctival haemorrhage, conjunctival hyperaemia, eye haemorrhage, eye pruritus, eyelid oedema, keratoconjunctivitis sicca, macular degeneration, ocular hyperaemia, pupils unequal, retinal detachment, retinal vascular disorder, retinopathy, visual acuity reduced, visual disturbance Ear and labyrinth disorders
Danish: Sjælden: Afaki, chorioretinopati, keratoconjunctivitis sicca, konjunktival blødning, konjunktival hyperæmi, maculadegeneration, nethindeløsning, okulær hyperæmi, retinopati, reduceret synsskarphed, synsforstyrrelse, uensartede pupiller, vaskulær sygdom i retina, øjenblødning,
English: Benign breast neoplasm, breast fibroma, chronic lymphocytic leukaemia, endometrial neoplasm, female reproductive neoplasm, haemangioma, hepatic neoplasm malignant, leiomyoma, melanocytic naevus, multiple myeloma, neoplasm, parathyroid tumour
Danish: hæmangiom, kronisk lymfatisk leukæmi, malignt leiomyom, melanocytisk nævus, multipelt myelom, neoplasme, neoplasme i endometrie, neoplasme i kvindelige reproduktionsorganer Blod og lymfesystem
English: Infections and infestations
Danish: Graviditet og amning
English: Common: Cystocele, endometrial disorder, endometrial hypertrophy* (sonographic endometrial thickness), uterine polyp, vaginal discharge, vaginal disorder Uncommon: Breast disorder female, breast induration, breast pain, cervix disorder, cervical dysplasia, cervical polyp, colpocele, endometrial hyperplasia** (based on investigator reporting), genital discharge, genital haemorrhage, hydrometra, metrorrhagia, postmenopausal haemorrhage, rectocele, uterine cervical erosion, uterine prolapse, vaginal haemorrhage, vaginal prolapse, vulvovaginal pruritus
Danish: Cervikal polyp, cervixsygdom, cervixdysplasi, endometriehyperplasi** (baseret på indrapportering fra investigator), erosion af cervix uteri, genitalt udflåd, genitalblødning, hydrometra, metroragi, mammasygdom, mammainduration, postmenopausal blødning, rectocele, smerter i mamma, uterusprolaps, vaginalblødning, vaginalprolaps, vaginalt hernie,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (28 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (28 filmovertrukne tabletter)
English: Excoriation, genital injury, limb injury, skeletal injury, soft tissue injury, spinal fracture, thoracic vertebral fracture, tooth fracture
Danish: Traumer, forgiftninger og behandlingskomplikationer Sjælden: Afskrabning, bløddelslæsion, brysthvirvelfraktur, genital beskadigelse, rygsøjlefraktur, skade på ekstremiteter, skeletlæsion, tandfraktur
English: • Dizziness, altered sense of taste, seizures, migraine, weakness of arms or legs, sciatica (pain felt in the lower back, buttock, and/or various parts of the leg and foot; typically on one side of the
Danish: (smerter i lænd, balle, og/eller forskellige steder i benene og fødder, typisk i den ene side af kroppen)
English: General disorders and administration site conditions Common: Therapeutic response unexpected Uncommon: Chest pain, fatigue, feeling hot, oedema peripheral Rare:
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig Uventet terapeutisk respons
English: Driving and using machines
Danish: VIRKNING OG ANVENDELSE
English: 28 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 filmovertrukne tabletter
English: New radiographic vertebral fracture in patients without any prevalent fracture at baseline Percentage of patients with new fracture n=1,970
Danish: Nye radiografisk verificerede rygsøjlefrakturer hos patienter uden prævalent fraktur ved baseline
English: Common side effects:
Danish: Almindelige bivirkninger:
English: FABLYN is only for women after the menopause and must not be taken by women who can still become pregnant.
Danish: De må ikke tage FABLYN, hvis De stadig kan blive gravid.
English: Common: Constipation
Danish: Almindelig Obstipation
English: Safety and efficacy of FABLYN have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients (see section 4.2 and section 5.2).
Danish: Derfor bør der udvises forsigtighed ved brug af Fablyn til disse patienter (se pkt.
English: Microcrystalline cellulose
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, colloid vandfri Magnesiumstearat
English: Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
Danish: Hver filmovertruken tablet indeholder lasofoxifentartrat, der svarer til 500
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE PACK (90 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BEHOLDER (90 filmovertrukne tabletter)
English: Safety and efficacy of lasofoxifene have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients.
Danish: Sikkerhed og effekt af lasofoxifen er ikke undersøgt hos patienter med svær nyreinsufficiens.
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret FABLYN til Dem personligt.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Fibroma, uterine leiomyoma Rare:
Danish: cyster og polypper) Ikke almindelig:
English: Anorexia, decreased appetite, hypertriglyceridaemia, hypoalbuminaemia,
Danish: Sjælden: Anoreksi, hypertriglyceridæmi, hypoalbuminæmi, hypofosfatæmi, nedsat appetit, tetani,type
English: 30 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 30 filmovertrukne tabletter
English: Tablet core:
Danish: Oversigt over indlægssedlen:
English: In a population pharmacokinetic analysis, no discernible difference in lasofoxifene pharmacokinetics was detected in different racial groups.
Danish: Der er ikke set forskelle mellem forskellige racer i en populationsfarmakokinetisk analyse.
English: Uncommon: Back pain, neck pain, pain in extremity Rare:
Danish: Nakkesmerter, rygsmerter, smerter i ekstremiteter
English: Injury and poisoning Rare:
Danish: Sjælden: Venøs misdannelse
English: 7 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 filmovertrukne tabletter
English: Angioedema, dry skin, hair texture abnormal, nail disorder, onychoclasis,
Danish: Sjælden: Abdominalømhed, anal fissur, analspasme, colitis ulcerosa, duodenitis, dysfagi,
English: Silica, colloidal anhydrous
Danish: Sjælden: Hypokromasi, megaloblastær anæmi
English: Renal insufficiency:
Danish: Nedsat nyrefunktion:
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: RELEASE
Danish: Øjne
English: Uncommon: Abdominal pain, abdominal pain lower, abdominal pain upper, dry mouth, flatulence,
Danish: Abdominalsmerter, flatulens, gastritis, irritabel tyktarm, nedre abdominalsmerter,
English: FABLYN-treated and placebo-treated groups had similar incidences of endometrial hyperplasia and endometrial cancer (see section 5.1).
Danish: Der var ingen forskel i hyppigheden af endometriehyperplasi og endometriecancer mellem Fablynbehandlede og placebobehandlede grupper (se pkt.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: Aortic aneurysm, arterial occlusive disease, capillary disorder, embolism, haematoma, haemorrhage, intermittent claudication, lymphostasis, thrombosis, vascular stenosis, venous thrombosis, venous thrombosis limb Respiratory, thoracic and mediastinal disorders Uncommon: Cough, pulmonary embolism, rhinitis allergic Rare:
Danish: Sjælden: Aortaaneurisme, arterieokklusion, blødning, claudicatio intermittens, emboli, hæmatom, kapillærsygdom, lymfestase, trombose, vaskulær stenose, venetrombose, venetrombose i
English: Calculus bladder, hypercalciuria, hypertonic bladder, nephrosclerosis, urethral haemorrhage, urinary bladder polyp, urinary tract disorder Reproductive system and breast disorders
Danish: Hyppig vandladning, imperiøs vandladningstrang, nykturi, uretral sygdom, urininkontinens Sjælden: Hyperkalciuri, hyperton blære, nefrosklerose, polyp i urinblæren, sten i blæren, Der reproduktive system og mammae
English: Renal and urinary disorders
Danish: Luftveje, thorax og mediastinum
English: Adenomyosis, adnexa uteri cyst, adnexa uteri mass, breast discharge, breast engorgement, breast fibrosis, enlarged clitoris, fallopian tube cyst, nipple disorder, nipple pain, perineal laceration, pruritus genital, uterine cervical squamous metaplasia, uterine haemorrhage, uterine mass, vaginal erosion, vaginal inflammation, vaginal pain, vaginal wall congestion, varicose veins vulval, vulvar disorder Congenital, familial and genetic disorders Rare:
Danish: endometriosis interna, fibrose i bryst, flåd fra bryst, forstørrelse af mamma, forstørrelse af klitoris, genital kløe, laceration af perineum, pladeepitelmetaplasi i cervix uteri, smerter i brystvorte, udfyldning i adnexa uteri, uterin blødning, uterusudfyldning, vaginal erosion,
English: Cardiac failure, cardiomegaly, cor pulmonale, sinus arrest, supraventricular extrasystoles, tricuspid valve incompetence Vascular disorders Common: Hot flush Uncommon: Deep vein thrombosis, flushing, phlebitis, thrombophlebitis, thrombophlebitis superficial, venous stasis
Danish: Dyb venetrombose, flebit, overfladisk tromboflebit, rødmen, tromboflebit, venestase
English: 90 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 90 filmovertrukne tabletter
English: 28 capsules
Danish: 28 kapsler
English: EU/1/13/848/001 Erivedge
Danish: EU/1/13/848/001 Erivedge 150 mg hårde kapsler oral anvendelse Beholder (HDPE)
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU nummer) (Særnavn) navn
English: Immediate Packaging
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: PC: {number} SN: {number} NN: {number}
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: You should make sure you fully understand and remember the following:
Danish: Du bør sikre dig, at du fuldt ud forstår og kan huske følgende:
English: This will give your body a chance to recover.
Danish: Dette vil give din krop en chance for at komme sig.
English: However, no unacceptable risks appear to be present in this patient group.
Danish: Der syntes imidlertid ikke at forekomme nogen uacceptable risici i denne patientgruppe.
English: After Day 28, the next cycle will begin.
Danish: Efter dag 28 vil den næste cyklus begynde.
English: Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Danish: Tag kapslerne på tom mave; for eksempel mindst en time før du planlægger at spise morgenmad.
English: Supportive measures should be provided as necessary.
Danish: Understøttende forholdsregler bør gives efter behov.
English: • which days are your dosing days.
Danish: • Hvilke dage, der er dine doseringsdage.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 19 November 2014
Danish: Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 19. november 2014
English: Elderly patients (> 70 years of age)
Danish: Ældre patienter (> 70 år)
English: You may also need other treatments.
Danish: Du kan også have behov for en anden behandling.
English: • how many capsules you need to take every dosing day.
Danish: • Hvor mange kapsler du skal tage hver doseringsdag.
English: There may be up to 6 treatment periods (cycles).
Danish: Der kan være op til 6 behandlingsperioder (cykler).
English: Capsules should not be opened.
Danish: Kapslerne bør ikke åbnes.
English: Although the data is limited, tolerance in children is expected to be the same as in adults.
Danish: Selv om der er begrænsede data, forventes tolerancen hos børn at være den samme som hos voksne.
English: Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Danish: Opnåelse af en radiologisk objektiv respons eller opretholdelse af progressionsfri status var kraftigt forbundet med opretholdt eller forbedret livskvalitet.
English: Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
Danish: Når strålebehandlingen er færdig, skal du afbryde behandlingen i 4 uger.
English: {DD/MM/YYYY}
Danish: {DD/MM/ÅÅÅÅ}
English: In 43 patients stable disease was reported.
Danish: Stabil sygdom blev rapporteret hos 43 patienter.
English: Ask your doctor or pharmacist to write it down (including the colour).
Danish: Bed din læge eller apoteket om skrive det ned (herunder farve).
English: During treatment patients should be monitored and managed appropriately.
Danish: Under behandling bør patienterne overvåges og administreres hensigtsmæssigt.
English: SL-1526 Ljubljana Slovenia
Danish: SL-1526 Ljubljana Slovenien
English: The carton contains one bottle.
Danish: Kartonen indeholder én flaske.
English: The colour of the capsule cap is different for each strength (see in the table below).
Danish: Farven på kapslens hætte er forskellig for hver styrke (se tabellen nedenfor).
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Danish: Gennemgå doseringen med din læge, hver gang du starter på en ny cyklus, da den kan være forskellig fra den sidste cyklus.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Danish: Figur 1 Kaplan-Meier-kurver for total overlevelse (intent-to-treat population)
English: This latency period is very short even for an alkylating agent.
Danish: Denne latensperiode er meget kort selv for et alkyleringsmiddel.
English: No evidence of cumulative myelosuppression was observed.
Danish: Der sås ingen tegn på kumulativ myelosuppression.
English: See footnote b
Danish: Se fodnote b
English: During treatment a complete blood count should be obtained weekly.
Danish: Under behandling bør en komplet blodundersøgelse foretages ugentligt.
English: • inability to fall asleep or stay asleep
Danish: • manglende evne til at falde i søvn eller sove igennem
English: Tell your doctor if you notice any of these symptoms.
Danish: Fortæl det til din læge, hvis du bemærker nogle af disse symptomer.
English: These blood cells are important for fighting infection and for proper blood clotting.
Danish: Disse blodceller er vigtige i bekæmpelsen af infektioner og for korrekt størkning af blodet.
English: Do not give this medicine to children under the age of 3 years because it has not been studied.
Danish: Anvend ikke dette lægemiddel til børn under 3 år, da der ikke er foretaget studier.
English: • severe headache that does not go away.
Danish: • kraftig hovedpine, som ikke går væk.
English: In the event of an overdose, haematological evaluation is needed.
Danish: I tilfælde af en overdosis er hæmatologisk vurdering nødvendig.
English: Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, medmindre din læge beder dig gøre dette.
English: Your doctor will work out your exact dose.
Danish: Din læge vil fastsætte din eksakte dosis.
English: TMZ can have genotoxic effects.
Danish: TMZ kan have genotoksiske virkninger.
English: The major route of 14C elimination is renal.
Danish: Den vigtigste eliminationsvej for 14C er renal udskillelse.
English: Take the missed dose as soon as possible during the same day.
Danish: Tag den glemte dosis så snart som muligt samme dag.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The objective response rate (ORR) based on MRI scans was 8 %.
Danish: Den objektive responsrate (ORR) baseret på MRI-scanninger var 8 %.
English: • as you may have a small risk of other changes in blood cells, including leukaemia.
Danish: • da du kan have en lille risiko for andre ændringer i blodcellerne, herunder leukæmi.
English: Keep the bottles tightly closed in order to protect from moisture.
Danish: Hold flasken tæt tillukket for at beskytte mod fugt.
English: For the eligible histology population, the efficacy results were similar.
Danish: For populationen med vurderbar histologi var resultaterne for effekten tilsvarende.
English: Opportunistic infections, including PCP
Danish: Opportunistiske infektioner, herunder PCP
English: The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
Danish: Kapslerne skal sluges hele med et glas vand og må ikke åbnes eller tygges.
English: • dry or painful eyes
Danish: • tørre eller smertefulde øjne
English: Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
Danish: Din læge vil regelmæssigt undersøge dit blod for eventuelle ændringer, og vil afgøre, om det er nødvendigt med en bestemt behandling.
English: • dose level -1 (100 mg/m2) still results in unacceptable toxicity
Danish: • dosisniveau -1 (100 mg/m2) fortsat resulterer i uacceptabel toksicitet.
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Danish: Indtagelse af TMZ med føde resulterede i et 33 % fald i Cmax og et 9 % fald i arealet under kurven (AUC).
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
Danish: CTC Grad 4b a: TMZ-dosisniveau er anført i Tabel 2. b: TMZ skal seponeres, hvis:
English: • change in mental status or alertness
Danish: • ændring i mental tilstand eller årvågenhed
English: Swallow the capsule(s) whole with a glass of water.
Danish: Slug kapslen (kapslerne) hele sammen med et glas vand.