FrancophonIA/ELRC3.0 huggingface dataset:
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol
Danish: GANFORT 0,3 mg/ml + 5 mg/ml øjendråber, opløsning bimatoprost/timolol
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om GANFORT findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Ocular use.
Danish: Til øjendrypning.
English: How to use GANFORT single-dose
Danish: Sådan skal De bruge GANFORT enkeltdosis
English: Ophthalmic beta-blockers may induce dryness of eyes.
Danish: Oftalmiske betablokkere kan fremkalde øjentørhed.
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol
Danish: GANFORT 0,3 mg/ml + 5 mg/ml øjendråber, opløsning, i enkeltdosisbeholder bimatoprost/timolol
English: 5 How to store GANFORT Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: What GANFORT single-dose is and what it is used for What you need to know before you use GANFORT single-dose How to use GANFORT single-dose Possible side effects
Danish: Det skal De vide, før De begynder at bruge GANFORT enkeltdosis Sådan skal De bruge GANFORT enkeltdosis Bivirkninger
English: The change may be more noticeable if you are only treating one eye. GANFORT may cause hair growth when in contact with the skin surface.
Danish: GANFORT kan måske forårsage hårvækst, når det kommer i kontakt med hudoverfladen.
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container.
Danish: GANFORT 0,3 mg/ml + 5 mg/ml øjendråber, opløsning, i enkeltdosisbeholder
English: GANFORT single-dose has a rapid onset of action.
Danish: Opbevar GANFORT enkeltdosis utilgængeligt for børn.
English: What GANFORT looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Put the cap back on and close the bottle straight after you have used it.
Danish: Skru låget på igen umiddelbart efter brug.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE POSE INDEHOLDENDE STRIP MED 10 ENKELTDOSISBEHOLDERE
English: If a drop misses your eye, try again.
Danish: Dryp igen, hvis dråben løber ved siden af øjet.
English: June 2023
Danish: Juni 2023
English: • go to the hospital straight away
Danish: • Tag straks på hospitalet.
English: If a child or young person accidentally takes Erleada:
Danish: Hvis et barn eller en ung person ved et uheld tager Erleada:
English: There were no grade 3 or 4 adverse events.
Danish: Der var ingen hændelser af grad 3 eller 4.
English: Biotransformation Following single oral administration of
Danish: Biotransformation Efter enkelt oral administration af
English: While the overall number of events was small, the difference between the two arms was sufficiently large to reach statistical significance.
Danish: Selvom det samlede antal hændelser var lavt, var forskellen mellem de to arme tilstrækkeligt stor til at opnå statistisk signifikans.
English: • You can take Erleada with food or between meals.
Danish: • Du kan tage Erleada sammen med mad eller mellem måltider.
English: Ethnicity and race
Danish: Etnicitet og race
English: Children and adolescents This medicine is not for use in children and adolescents under 18 years of age.
Danish: Børn og unge Dette lægemiddel er ikke beregnet til brug hos børn og unge under 18 år.
English: • has not metastasised to other parts of the body and
Danish: • ikke har metastaseret (spredt sig) til andre dele af kroppen og
English: Take extra care to reduce your risk of a fall.
Danish: Udvis ekstra forsigtighed for at nedsætte din risiko for at falde.
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke dette lægemiddel, hvis noget af ovenstående gælder for dig.
English: The tablets should be swallowed whole and can be taken with or without food.
Danish: Tabletterne skal synkes hele og kan tages sammen med eller uden mad.
English: There are no data available from the use of Erleada in pregnant women.
Danish: Der er ingen data fra anvendelse af Erleada til gravide kvinder.
English: Information for women
Danish: Oplysninger til kvinder
English: Androgens can cause the cancer to grow.
Danish: Androgener kan få kræften til at vokse.
English: There is also a risk of increased formation of active metabolites.
Danish: Der er også en risiko for øget dannelse af aktive metabolitter.
English: Treatment with Erleada significantly improved MFS.
Danish: Behandling med Erleada forbedrede MFS signifikant.
English: • Take this medicine by mouth.
Danish: • Dette lægemiddel skal tages gennem munden.
English: OTHER Fold over to close
Danish: Fold sammen for at lukke
English: PSA results were blinded and were not used for treatment discontinuation.
Danish: PSA-resultaterne var blindede og blev ikke anvendt til behandlingsseponering.
English: Each carton contains one bottle.
Danish: Hver karton indeholder én beholder.
English: The median time to symptomatic progression was not reached in either treatment group.
Danish: Mediantiden til symptomatisk progression blev ikke nået i nogen af behandlingsgrupperne.
English: The racial distribution was 66% Caucasian, 5.6% Black, 12% Asian, and 0.2% Other.
Danish: Den racemæssige fordeling var 66 % kaukasiere, 5,6 % sorte, 12 % asiater og 0,2% andet.
English: Your doctor may also prescribe other medicines while you are taking Erleada.
Danish: Lægen kan også ordinere anden medicin, mens du tager Erleada.
English: Information for men - follow this advice during treatment and for 3 months after stopping
Danish: Oplysninger til mænd - Følg disse råd under behandlingen og i 3 måneder efter ophør af behandlingen
English: Table 1: Adverse reactions identified in clinical studies
Danish: Tabel 1: Bivirkninger påvist i kliniske studier
English: You may have an increased risk of side effects.
Danish: Du kan have en øget risiko for bivirkninger.
English: The mean effective half-life for apalutamide in patients is about 3 days at steady-state.
Danish: Apalutamids gennemsnitlige effektive halveringstid hos patienter er cirka 3 dage ved steady state.
English: Patients should be advised of this risk in regards to driving or operating machines.
Danish: Patienter bør advares om denne risiko med hensyn til at føre motorkøretøj og betjene maskiner.
English: The following patient demographics and baseline disease characteristics were balanced between the treatment arms.
Danish: Følgende patientdemografi og sygdomskarakteristika ved baseline var afbalancerede mellem behandlingsgrupperne.
English: If you are at higher risk of seizures (see Section 2), talk to your doctor.
Danish: Hvis du har en høj risiko for krampeanfald (se punkt 2), skal du kontakte lægen.
English: Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Danish: Administration sammen med warfarin og coumarin-lignende antikoagulantia bør undgås.
English: Effects on male rats were reversible after 8 weeks from the last apalutamide administration.
Danish: Virkningerne på hanrotter var reversible 8 uger efter den sidste administration af apalutamid.
English: The dose of Erleada or any other medicines that you are taking may need to be changed.
Danish: Det kan være nødvendigt at ændre dosen af Erleada eller andre lægemidler, du tager.
English: Erleada may harm your unborn baby.
Danish: Erleada kan skade det ufødte barn.
English: Half of the patients experienced a fall within 7 days before the fracture event in both treatment groups.
Danish: Halvdelen af patienterne var faldet op til 7 dage inden frakturhændelsen i begge behandlingsgrupper.
English: It is used to treat adult men with prostate cancer that:
Danish: Det anvendes til behandling af voksne mænd med prostatakræft, som:
English: Erleada works by blocking the activity of hormones called androgens (such as testosterone).
Danish: Erleada virker ved at blokere aktiviteten af hormoner, der kaldes for androgener (såsom testosteron).
English: The median MFS for Erleada was 41 months and was 16 months for placebo (see Figure 1.
Danish: Median MFS var 41 måneder for Erleada og 16 måneder for placebo (se figur 1).
English: If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.
Danish: Hvis en dosis glemmes, skal denne tages snarest muligt den samme dag, hvorefter der fortsættes med den normale plan den efterfølgende dag.
English: Talk to your doctor if you have any questions about contraception.
Danish: Kontakt lægen, hvis du har spørgsmål vedrørende prævention.
English: • no longer responds to medical or surgical treatment that lowers testosterone (also called castration-resistant prostate cancer).
Danish: • ikke længere reagerer på medicinsk eller kirurgisk behandling, der sænker testosteron (også kaldet kastrationsresistent prostatakræft).
English: All subjects who were not surgically castrated received ADT continuously throughout the study.
Danish: Alle forsøgsdeltagere, som ikke var kirurgisk kastreret, fik kontinuerlig ADT i hele studiet.
English: The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect.
Danish: Reduktionen i plasmakoncentrationerne kan være betydelig og medføre manglende eller nedsat klinisk virkning.
English: Pharmacotherapeutic group: Endocrine therapy, anti-androgens, ATC code: L02BB05
Danish: Farmakoterapeutisk klassifikation: Endokrin terapi, anti-androgener, ATC-kode: L02BB05
English: • feeling very tired
Danish: • udpræget træthed
English: Substitution for these medicinal products is recommended when possible or evaluation for loss of efficacy should be performed if the medicinal product is continued.
Danish: Det anbefales at substituere disse lægemidler, hvor dette er muligt, eller at evaluere for manglende virkning, hvis lægemidlet fortsættes.
English: Pregnancy and contraception information for men and women
Danish: Oplysninger om graviditet og prævention til mænd og kvinder
English: This is because Erleada can affect the way some other medicines work.
Danish: Det skyldes, at Erleada kan påvirke virkningen af visse andre lægemidler.
English: The potential effect of severe renal impairment or end stage renal disease (eGFR ≤29 mL/min/1.73 m2) have not been established due to insufficient data.
Danish: Den potentielle indvirkning af svær nyreinsufficiens eller terminal nyresygdom (eGFR ≤ 29 ml/min/1,73 m2) er ikke blevet klarlagt på grund af utilstrækkelige data.
English: You need to list the names of the medicines you take and show the list to your doctor or pharmacist when you start a new medicine.
Danish: Du skal lave en liste over de lægemidler, du tager, og vise listen til lægen eller apotekspersonalet, når du starter på et nyt lægemiddel.
English: Long-term animal studies have not been conducted to evaluate the carcinogenic potential of apalutamide.
Danish: Der er ikke udført langvarige dyreforsøg for at evaluere apalutamids karcinogene potentiale.
English: In the event of an overdose, Erleada should be stopped and general supportive measures should be undertaken until clinical toxicity has been diminished or resolved.
Danish: I tilfælde af en overdosis skal behandlingen med Erleada stoppes, og der skal iværksættes almene understøttende tiltag, indtil den kliniske toksicitet er reduceret eller forsvundet.
English: Mean absolute oral bioavailability is approximately 100%, indicating that apalutamide is completely absorbed after oral administration.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er cirka 100 %, hvilket indikerer, at apalutamid absorberes fuldstændigt efter oral administration.
English: 28-day carton
Danish: 28-dages karton
English: Not known (frequency cannot be estimated from the available data): • abnormal heart tracing on an ECG (electrocardiogram)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) • uregelmæssig hjerteaktivitet på et EKG (elektrokardiogram)
English: 30-day carton
Danish: 30-dages karton
English: If you forget to take Erleada, take your usual dose as soon as you remember.
Danish: Hvis du glemmer at tage Erleada, skal du tage den sædvanlige dosis, så snart du kommer i tanke om det.
English: Other important adverse reactions include fractures (12%) and hypothyroidism (8%).
Danish: Andre vigtige bivirkninger omfatter frakturer (12 %) og hypothyreoidisme (8 %).
English: Tell your doctor straight away if you notice any of the following serious side effects - your doctor may stop treatment:
Danish: Alvorlige bivirkninger Kontakt straks lægen, hvis du bemærker en af følgende alvorlige bivirkninger - lægen vil eventuelt stoppe behandlingen:
English: Based on its mechanism of action, Erleada may cause foetal harm when administered during pregnancy.
Danish: Erleada kan som følge af dets virkningsmekanisme forårsage fosterskader, hvis det administreres under graviditeten.
English: Figure 1: Kaplan-Meier metastasis-free survival (MFS) curve in Study ARN-509-003
Danish: Figur 1: Kaplan-Meier-kurve over metastasefri overlevelse (MFS) i studie ARN-509-003
English: Therefore, the safety of apalutamide in these patients has not been established.
Danish: Derfor er sikkerheden af apalutamid ikke blevet klarlagt hos sådanne patienter.
English: All subjects enrolled were confirmed to be non-metastatic by blinded central imaging review and had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status score of 0 or 1 at study entry.
Danish: Alle inkluderede forsøgsdeltagere blev bekræftet at være ikke-metastatiske ved en blindet central billedgennemgang og havde en ECOG-PS (Eastern Cooperative Oncology Group Performance Status) på 0 eller 1 ved optagelsen i studiet.
English: Medicinal products utilised included topical corticosteroids, systemic corticosteroids and oral anti-histamines.
Danish: Anvendte lægemidler omfattede topikale kortikosteroider, systemiske kortikosteroider og orale antihistaminer.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al medicin give bivirkninger, men ikke alle får bivirkninger.
English: • If you forget to take Erleada for more than one day - talk to your doctor straight away.
Danish: • Hvis du glemmer at tage Erleada i mere end én dag, skal du straks kontakte lægen.
English: Titanium dioxide (E171)
Danish: Talcum Titandioxid (E 171)
English: A majority of subjects had a Gleason score of 7 or higher (81%).
Danish: Størstedelen af forsøgsdeltagerne havde en Gleason-score på 7 eller derover (81 %).
English: The median age was 74 years (range 48-97) and 26% of subjects were 80 years of age or older.
Danish: Medianalderen var 74 år (interval 48-97), og 26 % af forsøgsdeltagerne var 80 år eller ældre.
English: • blood test showing high level of cholesterol in the blood
Danish: • blodprøve, der viser højt kolesterolindhold i blodet
English: The median days to onset of skin rash was 82 days with a range of 1 to 994 days.
Danish: Mediantiden til indtræden af hududslæt var 82 dage med et interval på 1 til 994 dage.
English: The tablets are supplied in a plastic bottle with a child-resistant closure.
Danish: Tabletterne udleveres i en plastbeholder med børnesikret lukning.
English: Population pharmacokinetic analyses showed that age (range: 18 to 94 years) does not have a clinically meaningful influence on the pharmacokinetics of apalutamide.
Danish: Farmakokinetiske populationsanalyser viste, at alder (interval: 18 til 94 år) ikke har nogen klinisk relevant indvirkning på apalutamids farmakokinetik.
English: Concomitant use with other medicinal products
Danish: Samtidig brug af andre lægemidler
English: The European Medicines Agency has waived the obligation to submit the results of studies with Erleada in all subsets of the paediatric population in advanced prostate cancer.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Erleada i alle undergrupper af den pædiatriske population med fremskreden prostatacancer.
English: By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing.
Danish: Ved at blokere virkningen af androgener forhindrer apalutamid prostatakræftcellerne i at vokse og dele sig.
English: • blood test showing high level of a type of fat called “triglycerides” in the blood
Danish: • blodprøve, der viser højt indhold af en type fedt, der kaldes for ”triglycerider”, i blodet
English: The effects of renal impairment, hepatic impairment, age, race, and other extrinsic factors on the pharmacokinetics of apalutamide are summarised below.
Danish: Indvirkningen af nedsat nyrefunktion, nedsat leverfunktion, alder, race og andre ekstrinsiske faktorer på apalutamids farmakokinetik er opsummeret nedenfor.
English: Erleada contains sodium
Danish: Erleada indeholder natrium
English: Time to symptomatic progression was defined as time from randomization to development of a skeletal related event, pain/symptoms requiring initiation of a new systemic anti-cancer therapy, or loco-regional tumor progression requiring radiation/surgery.
Danish: Tid til symptomatisk progression var defineret som tiden fra randomisering til udvikling af en skeletrelateret hændelse, smerter/symptomer, der krævede iværksættelse af en ny systemisk cancerbehandling, eller lokoregional tumorprogression, der krævede strålebehandling/kirurgi.
English: For patients having sex with female partners of reproductive potential, a condom should be used along with another highly effective contraceptive method during treatment and for 3 months after the last dose of Erleada.
Danish: Patienter, der dyrker sex med fertile kvinder, skal anvende kondom sammen med en anden højeffektiv kontraceptionsmetode under behandlingen og i 3 måneder efter den sidste dosis af Erleada.
English: Use contraception during treatment and for 3 months after stopping.
Danish: Brug prævention under behandlingen og i 3 måneder efter ophør af behandlingen.
English: Endocrine disorders common: hypothyroidism*
Danish: Det endokrine system almindelig: hypothyreoidisme*
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Danish: De bivirkninger, der er observeret i kliniske studier, er anført nedenfor efter hyppighed.
English: If you are taking any medicines, talk to your doctor or pharmacist to see if they are associated with an increased risk of seizure, bleeding, or heart condition.
Danish: Hvis du tager anden medicin, skal du kontakte lægen eller apotekspersonalet for at høre, om den er forbundet med en øget risiko for krampeanfald, blødning eller hjertesygdom.
English: It is unknown whether apalutamide/metabolites are excreted in human milk.
Danish: Det er ukendt, om apalutamid/metabolitter udskilles i human mælk.
English: Following administration of 240 mg once daily, apalutamide steady state was achieved after 4 weeks and the mean accumulation ratio was approximately 5-fold relative to a single dose.
Danish: Efter administration af 240 mg én gang dagligt blev steady state af apalutamid nået efter 4 uger, og den gennemsnitlige akkumulationsratio var cirka 5-foldig i forhold til en enkeltdosis.
English: After oral administration, median time to achieve peak plasma concentration (tmax) was 2 hours (range: 1 to 5 hours).
Danish: Efter oral administration var mediantiden til opnåelse af den maksimale plasmakoncentration (tmax) 2 timer (interval: 1 til 5 timer).
English: The effect of apalutamide on CYP2B6 substrates has not been evaluated in vivo and the net effect is presently unknown.
Danish: Apalutamids virkning på CYP2B6-substrater er ikke blevet undersøgt in vivo, og nettoeffekten er ukendt på nuværende tidspunkt.
English: If a seizure develops during treatment with Erleada, treatment should be discontinued permanently.
Danish: Hvis der opstår et krampeanfald under behandlingen med Erleada, skal behandlingen seponeres permanent.
English: Administration of apalutamide to healthy subjects under fasting conditions and with a high-fat meal resulted in no clinically relevant changes in Cmax and AUC.
Danish: Administration af apalutamid til raske forsøgsdeltagere under faste og sammen med et måltid med et højt fedtindhold resulterede ikke i klinisk relevante forandringer i Cmax og AUC.
English: Based on population pharmacokinetic analysis, there were no clinically relevant differences in apalutamide pharmacokinetics between White (Caucasian or Hispanic or Latino; N=761), Black (of African heritage or African American; N=71), Asian (non-Japanese; N=58) and Japanese (N=58).
Danish: Baseret på en farmakokinetisk populationsanalyse var der ingen klinisk relevante forskelle i apalutamids farmakokinetik hos hvide (kaukasiere eller latinamerikanere; N = 761), sorte (af afrikansk afstamning eller afroamerikanere; N = 71), asiater (ikke-japanske; N = 58) og japanere (N = 58).
English: Among patients with skin rash, dose interruption occurred in 28% and dose reduction occurred in 12% (see section 4.2).
Danish: Blandt patienterne med hududslæt blev doseringen afbrudt hos 28 %, og dosis blev reduceret hos 12 % (se pkt.
English: The mean apparent volume of distribution at steady-state of apalutamide is about 276 L. The volume of distribution of apalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen ved steady state af apalutamid er cirka 276 l. Apalutamids fordelingsvolumen er større end det totale vandvolumen i kroppen, hvilket viser, at der er omfattende ekstravaskulær fordeling.
English: Consistent improvement in MFS with Erleada was observed for all prespecified subgroups, including age, race, region of the world, nodal status, prior number of hormonal therapies, baseline PSA, PSA doubling time, baseline ECOG status and use of bone-sparing agents.
Danish: Der blev set en konsekvent forbedring i MFS med Erleada i alle forudbestemte undergrupper, inklusive alder, race, verdensregion, nodalstatus, forudgående antal hormonelle behandlinger, baseline-PSA, PSA-fordoblingstid, ECOG-status ved baseline og brug af knoglestyrkende lægemidler.
English: Your healthcare provider may monitor you more closely if you are at risk for fractures.
Danish: Sundhedspersonalet vil eventuelt følge dig tættere, hvis du har risiko for brud.
English: • you are a woman who is pregnant or may become pregnant (see the Pregnancy and contraception section below for more information).
Danish: • hvis du er kvinde, og du er gravid eller kan blive gravid (se yderligere oplysninger i afsnittet om graviditet og prævention nedenfor).
English: Polyvinyl alcohol (partially hydrolysed) Talc
Danish: Polyvinylalkohol (delvist hydrolyseret)
English: Do not stop taking Erleada without checking with your doctor first.
Danish: Hvis du holder op med at tage Erleada Du må ikke holde op med at tage Erleada uden at drøfte det med din læge først.
English: If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Danish: Hvis patienten oplever toksicitet ≥ grad 3 eller en uacceptabel bivirkning, bør doseringen afbrydes midlertidigt (frem for at seponere behandlingen permanent), indtil symptomerne bedres til ≤ grad 1 eller den oprindelige grad, hvorefter den genoptages med samme dosis eller om nødvendigt en reduceret dosis (180 mg eller 120 mg).
English: Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Danish: Behandling med apalutamid bør iværksættes og overvåges af speciallæger med erfaring i medicinsk behandling af prostatacancer.
English: Seventy-seven percent (77%) of subjects in both treatment arms had prior surgery or radiotherapy of the prostate.
Danish: Syvoghalvfjerds procent (77 %) af forsøgsdeltagerne i begge behandlingsarme havde gennemgået tidligere operation eller strålebehandling af prostata.