natgillin/translations-raw huggingface dataset:
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 28 tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 28 tablets
Almindelig Hyperhidrose 
Lactose monohydrate
Dosisjustering er ikke nødvendig hos patienter med mild til moderat leverinsufficiens (se pkt. 
No dose adjustment is required in patients with mild to moderate hepatic insufficiency (see section 5.2).
SÅDAN SKAL DE TAGE FABLYN 
HOW TO TAKE FABLYN
• Tør hud, unormal hårstruktur, negleproblemer, hudkløe, mørkfarvning af huden, ændring af fingrenes form, læsioner i huden 
• 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,
Dosisjustering er ikke nødvendig hos patienter med mild til moderat nyreinsufficiens (se pkt. 
No dose adjustment is necessary in patients with mild or moderate renal insufficiency (see section 5.2).
• Ikke almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 1.000 patienter 
• Uncommon: affects 1 to 10 users in 1,000
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. 
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).
Derfor er sikkerhed og effekt ikke undersøgt hos børn og unge under 18 år (se pkt. 
Therefore safety and efficacy have not been studied (see section 5.2).
Knogleomsætning 
Lactation
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). 
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).
• Hoste, vejrtrækningsbesvær, tilstoppet næse, løbende næse 
• Cough, difficulty breathing, stuffy nose, runny nose
2 diabetes mellitus, øget appetit 
hypophosphataemia, increased appetite, tetany, type 2 diabetes mellitus Psychiatric disorders
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (7 filmovertrukne tabletter) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (7 film-coated tablets)
Følgende stoffer har ingen klinisk relevant indvirkning på lasofoxifens farmakokinetik: cholestyramin (anionbytter-resin), fluconazol (CYP2C9-inhibitor), ketoconazol (CYP3A4/5-inhibitor) og paroxetin (CYP2D6-inhibitor). 
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.
Tørre øjne 
stomach ache
LÆGEMIDLETS NAVN FABLYN 500 mikrogram Filmovertrukne tabletter lasofoxifen 
NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets lasofoxifene
• Læsion på læben, ændring i tarmfloraen, besvær med at synke, mundsår, halsbrand, smerter i munden, endetarmssmerter 
• 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,
Fablyn må ikke anvendes til ammende kvinder (se pkt. 
FABLYN must not be taken during lactation (see section 4.3).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (30 filmovertrukne tabletter) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (30 film-coated tablets)
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. 
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).
Sjælden: Galdegangssten, gulsot, hepatitis, kolecystitis, leversygdom Hud og subkutane væv 
Bile duct stone, cholecystitis, hepatitis, jaundice, liver disorder Skin and subcutaneous tissue disorders Common Hyperhidrosis
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN 
CONDITIONS OF THE MARKETING AUTHORISATION
Hvis De har taget for FABLYN Kontakt lægen eller apoteket, hvis De har taget flere tabletter, end lægen har foreskrevet. 
If you take more tablets than you should, tell your doctor or pharmacist.
Hvis De holder op med at tage FABLYN Kontakt lægen, hvis De ønsker at stoppe behandlingen med FABLYN. 
You should talk to your doctor before stopping FABLYN.
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 
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:
Sjælden: Afaki, chorioretinopati, keratoconjunctivitis sicca, konjunktival blødning, konjunktival hyperæmi, maculadegeneration, nethindeløsning, okulær hyperæmi, retinopati, reduceret synsskarphed, synsforstyrrelse, uensartede pupiller, vaskulær sygdom i retina, øjenblødning, 
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
hæmangiom, kronisk lymfatisk leukæmi, malignt leiomyom, melanocytisk nævus, multipelt myelom, neoplasme, neoplasme i endometrie, neoplasme i kvindelige reproduktionsorganer Blod og lymfesystem 
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
Graviditet og amning 
Infections and infestations
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, 
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
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING (28 filmovertrukne tabletter) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK (28 film-coated tablets)
Traumer, forgiftninger og behandlingskomplikationer Sjælden: Afskrabning, bløddelslæsion, brysthvirvelfraktur, genital beskadigelse, rygsøjlefraktur, skade på ekstremiteter, skeletlæsion, tandfraktur 
Excoriation, genital injury, limb injury, skeletal injury, soft tissue injury, spinal fracture, thoracic vertebral fracture, tooth fracture
(smerter i lænd, balle, og/eller forskellige steder i benene og fødder, typisk i den ene side af kroppen) 
• 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
Almene symptomer og reaktioner på administrationsstedet Almindelig Uventet terapeutisk respons 
General disorders and administration site conditions Common: Therapeutic response unexpected Uncommon: Chest pain, fatigue, feeling hot, oedema peripheral Rare:
VIRKNING OG ANVENDELSE 
Driving and using machines
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 filmovertrukne tabletter 
28 film-coated tablets
Nye radiografisk verificerede rygsøjlefrakturer hos patienter uden prævalent fraktur ved baseline 
New radiographic vertebral fracture in patients without any prevalent fracture at baseline Percentage of patients with new fracture n=1,970
Almindelige bivirkninger: 
Common side effects:
De må ikke tage FABLYN, hvis De stadig kan blive gravid. 
FABLYN is only for women after the menopause and must not be taken by women who can still become pregnant.
Almindelig Obstipation 
Common: Constipation
Derfor bør der udvises forsigtighed ved brug af Fablyn til disse patienter (se pkt. 
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).
Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, colloid vandfri Magnesiumstearat 
Microcrystalline cellulose
Hver filmovertruken tablet indeholder lasofoxifentartrat, der svarer til 500 
Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BEHOLDER (90 filmovertrukne tabletter) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE PACK (90 film-coated tablets)
Sikkerhed og effekt af lasofoxifen er ikke undersøgt hos patienter med svær nyreinsufficiens. 
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.
• Lægen har ordineret FABLYN til Dem personligt. 
• This medicine has been prescribed for you.
cyster og polypper) Ikke almindelig: 
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Fibroma, uterine leiomyoma Rare:
Sjælden: Anoreksi, hypertriglyceridæmi, hypoalbuminæmi, hypofosfatæmi, nedsat appetit, tetani,type 
Anorexia, decreased appetite, hypertriglyceridaemia, hypoalbuminaemia,
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 30 filmovertrukne tabletter 
30 film-coated tablets
Oversigt over indlægssedlen: 
Tablet core:
Der er ikke set forskelle mellem forskellige racer i en populationsfarmakokinetisk analyse. 
In a population pharmacokinetic analysis, no discernible difference in lasofoxifene pharmacokinetics was detected in different racial groups.
Nakkesmerter, rygsmerter, smerter i ekstremiteter 
Uncommon: Back pain, neck pain, pain in extremity Rare:
Sjælden: Venøs misdannelse 
Injury and poisoning Rare:
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 filmovertrukne tabletter 
7 film-coated tablets
Sjælden: Abdominalømhed, anal fissur, analspasme, colitis ulcerosa, duodenitis, dysfagi, 
Angioedema, dry skin, hair texture abnormal, nail disorder, onychoclasis,
Sjælden: Hypokromasi, megaloblastær anæmi 
Silica, colloidal anhydrous
Nedsat nyrefunktion: 
Renal insufficiency:
DATO FOR ÆNDRING AF TEKSTEN 
DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Øjne 
RELEASE
Abdominalsmerter, flatulens, gastritis, irritabel tyktarm, nedre abdominalsmerter, 
Uncommon: Abdominal pain, abdominal pain lower, abdominal pain upper, dry mouth, flatulence,
Der var ingen forskel i hyppigheden af endometriehyperplasi og endometriecancer mellem Fablynbehandlede og placebobehandlede grupper (se pkt. 
FABLYN-treated and placebo-treated groups had similar incidences of endometrial hyperplasia and endometrial cancer (see section 5.1).
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her. 
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.
Sjælden: Aortaaneurisme, arterieokklusion, blødning, claudicatio intermittens, emboli, hæmatom, kapillærsygdom, lymfestase, trombose, vaskulær stenose, venetrombose, venetrombose i 
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:
Hyppig vandladning, imperiøs vandladningstrang, nykturi, uretral sygdom, urininkontinens Sjælden: Hyperkalciuri, hyperton blære, nefrosklerose, polyp i urinblæren, sten i blæren, Der reproduktive system og mammae 
Calculus bladder, hypercalciuria, hypertonic bladder, nephrosclerosis, urethral haemorrhage, urinary bladder polyp, urinary tract disorder Reproductive system and breast disorders
Luftveje, thorax og mediastinum 
Renal and urinary disorders
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, 
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:
Dyb venetrombose, flebit, overfladisk tromboflebit, rødmen, tromboflebit, venestase 
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
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 90 filmovertrukne tabletter 
90 film-coated tablets
28 kapsler 
28 capsules
EU/1/13/848/001 Erivedge 150 mg hårde kapsler oral anvendelse Beholder (HDPE) 
EU/1/13/848/001 Erivedge
MF (EU nummer) (Særnavn) navn 
MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Styrke Lægemiddelform Administration Emballage Pakningsstørrelse 
Immediate Packaging
PC: {nummer} SN: {nummer} NN: {nummer} 
PC: {number} SN: {number} NN: {number}
Du bør sikre dig, at du fuldt ud forstår og kan huske følgende: 
You should make sure you fully understand and remember the following:
Dette vil give din krop en chance for at komme sig. 
This will give your body a chance to recover.
Der syntes imidlertid ikke at forekomme nogen uacceptable risici i denne patientgruppe. 
However, no unacceptable risks appear to be present in this patient group.
Efter dag 28 vil den næste cyklus begynde. 
After Day 28, the next cycle will begin.
Tag kapslerne på tom mave; for eksempel mindst en time før du planlægger at spise morgenmad. 
Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Understøttende forholdsregler bør gives efter behov. 
Supportive measures should be provided as necessary.
• Hvilke dage, der er dine doseringsdage. 
• which days are your dosing days.
Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 19. november 2014 
Date of first authorisation: 15 March 2010 Date of latest renewal: 19 November 2014
Ældre patienter (> 70 år) 
Elderly patients (> 70 years of age)
Du kan også have behov for en anden behandling. 
You may also need other treatments.
• Hvor mange kapsler du skal tage hver doseringsdag. 
• how many capsules you need to take every dosing day.
Der kan være op til 6 behandlingsperioder (cykler). 
There may be up to 6 treatment periods (cycles).
Kapslerne bør ikke åbnes. 
Capsules should not be opened.
Selv om der er begrænsede data, forventes tolerancen hos børn at være den samme som hos voksne. 
Although the data is limited, tolerance in children is expected to be the same as in adults.
Opnåelse af en radiologisk objektiv respons eller opretholdelse af progressionsfri status var kraftigt forbundet med opretholdt eller forbedret livskvalitet. 
Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Når strålebehandlingen er færdig, skal du afbryde behandlingen i 4 uger. 
Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
{DD/MM/ÅÅÅÅ} 
{DD/MM/YYYY}
Stabil sygdom blev rapporteret hos 43 patienter. 
In 43 patients stable disease was reported.
Bed din læge eller apoteket om skrive det ned (herunder farve). 
Ask your doctor or pharmacist to write it down (including the colour).
Under behandling bør patienterne overvåges og administreres hensigtsmæssigt. 
During treatment patients should be monitored and managed appropriately.
SL-1526 Ljubljana Slovenien 
SL-1526 Ljubljana Slovenia
Kartonen indeholder én flaske. 
The carton contains one bottle.
Farven på kapslens hætte er forskellig for hver styrke (se tabellen nedenfor). 
The colour of the capsule cap is different for each strength (see in the table below).
Gennemgå doseringen med din læge, hver gang du starter på en ny cyklus, da den kan være forskellig fra den sidste cyklus. 
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Figur 1 Kaplan-Meier-kurver for total overlevelse (intent-to-treat population) 
Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Denne latensperiode er meget kort selv for et alkyleringsmiddel. 
This latency period is very short even for an alkylating agent.
Der sås ingen tegn på kumulativ myelosuppression. 
No evidence of cumulative myelosuppression was observed.
Se fodnote b 
See footnote b
Under behandling bør en komplet blodundersøgelse foretages ugentligt. 
During treatment a complete blood count should be obtained weekly.
• manglende evne til at falde i søvn eller sove igennem 
• inability to fall asleep or stay asleep
Fortæl det til din læge, hvis du bemærker nogle af disse symptomer. 
Tell your doctor if you notice any of these symptoms.
Disse blodceller er vigtige i bekæmpelsen af infektioner og for korrekt størkning af blodet. 
These blood cells are important for fighting infection and for proper blood clotting.
Anvend ikke dette lægemiddel til børn under 3 år, da der ikke er foretaget studier. 
Do not give this medicine to children under the age of 3 years because it has not been studied.
• kraftig hovedpine, som ikke går væk. 
• severe headache that does not go away.
I tilfælde af en overdosis er hæmatologisk vurdering nødvendig. 
In the event of an overdose, haematological evaluation is needed.
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, medmindre din læge beder dig gøre dette. 
Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Din læge vil fastsætte din eksakte dosis. 
Your doctor will work out your exact dose.
TMZ kan have genotoksiske virkninger. 
TMZ can have genotoxic effects.
Den vigtigste eliminationsvej for 14C er renal udskillelse. 
The major route of 14C elimination is renal.
Tag den glemte dosis så snart som muligt samme dag. 
Take the missed dose as soon as possible during the same day.
• 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. 
• 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.
Den objektive responsrate (ORR) baseret på MRI-scanninger var 8 %. 
The objective response rate (ORR) based on MRI scans was 8 %.
• da du kan have en lille risiko for andre ændringer i blodcellerne, herunder leukæmi. 
• as you may have a small risk of other changes in blood cells, including leukaemia.
Hold flasken tæt tillukket for at beskytte mod fugt. 
Keep the bottles tightly closed in order to protect from moisture.
For populationen med vurderbar histologi var resultaterne for effekten tilsvarende. 
For the eligible histology population, the efficacy results were similar.
Opportunistiske infektioner, herunder PCP 
Opportunistic infections, including PCP
Kapslerne skal sluges hele med et glas vand og må ikke åbnes eller tygges. 
The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
• tørre eller smertefulde øjne 
• dry or painful eyes
Din læge vil regelmæssigt undersøge dit blod for eventuelle ændringer, og vil afgøre, om det er nødvendigt med en bestemt behandling. 
Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed.
• dosisniveau -1 (100 mg/m2) fortsat resulterer i uacceptabel toksicitet. 
• dose level -1 (100 mg/m2) still results in unacceptable toxicity
Indtagelse af TMZ med føde resulterede i et 33 % fald i Cmax og et 9 % fald i arealet under kurven (AUC). 
Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
CTC Grad 4b a: TMZ-dosisniveau er anført i Tabel 2. b: TMZ skal seponeres, hvis: 
CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
• ændring i mental tilstand eller årvågenhed 
• change in mental status or alertness
Slug kapslen (kapslerne) hele sammen med et glas vand. 
Swallow the capsule(s) whole with a glass of water.
Denne daglige dosis afhænger af, om du tidligere har modtaget kemoterapi. 
This daily dose depends on whether or not you have received chemotherapy before.
Interaktionsstudier er kun udført hos voksne. 
Paediatric population Interaction studies have only been performed in adults.
Følgende yderligere alvorlige bivirkninger er identificeret efter markedsføring: 
The following additional serious adverse reactions have been identified during post-marketing exposure:
Infektion, oral candidiasis 
Infection, candidiasis oral
Tolerancen over for TMZ er som hos voksne. 
Tolerance to TMZ is similar to adults.
TMZ er mere toksisk for rotter og hunde end for mennesker, og den kliniske dosis nærmer sig den mindste letale dosis hos rotter og hunde. 
TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”Exp”. 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temozolomide Sandoz indgives uden føde. 
As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Sandoz should be administered without food.
• Hvis du udvikler feber eller infektionssymptomer, skal du straks kontakte din læge. 
• if you develop fever or symptoms of an infection, contact your doctor immediately.