FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not breast-feed during your treatment or during the 20 months after your treatment has finished.
Danish: Du må ikke amme under behandling eller i de første 20 måneder, efter at din behandling er afsluttet.
English: Each hard capsule contains 38.6 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 38,6 mg lactosemonohydrat.
English: Patients should be instructed not to donate blood while taking Odomzo and for at least 20 months after ending treatment.
Danish: Det skal indskærpes over for patienter, at de ikke må give blod, så længe de tager Odomzo og i mindst 20 måneder efter endt behandling.
English: Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment.
Danish: Mænd må ikke befrugte en kvinde eller donere sæd, så længe de tager Odomzo og i mindst 6 måneder efter endt behandling.
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Danish: Ved lancering af produktet skal indehaveren af markedsføringstilladelsen udsende Direkte Sikkerhedsinformation til Sundhedspersonale, som skal indeholde følgende:
English: A woman of childbearing potential must understand that:
Danish: En fertil kvinde skal være klar over følgende:
English: The patient reminder card should contain the following key elements:
Danish: Informationskortet til patienter skal indeholde følgende vigtige informationer:
English: • a medicine called penicillamine used to treat rheumatoid arthritis
Danish: • medicin, som hedder penicillamin mod leddegigt
English: If you stop taking Odomzo
Danish: Hvis du har glemt at tage Odomzo
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg was increased 2.8- and 3.5-fold, respectively, when the dose was given with a light meal.
Danish: Sammenlignet med fastende tilstand steg Cmax og AUC for Odomzo 200 mg henholdsvis 2,8 og 3,5 gange, når dosis blev givet i forbindelse med et let måltid.
English: • you must keep using this contraception for 20 months after you have stopped taking Odomzo because traces of the medicine remain in the body for a long time.
Danish: • Du skal blive ved med at anvende denne prævention i 20 måneder efter, at du er holdt op med at tage
English: Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies.
Danish: Det skal du vide, før du begynder at tage Odomzo Følg alle lægens anvisninger omhyggeligt, særligt om Odomzos virkninger på ufødte babyer.
English: Odomzo 200 mg hard capsules sonidegib
Danish: Odomzo 200 mg hårde kapsler sonidegib
English: In healthy subjects, co-administration of a single dose of 800 mg sonidegib with rifampicin (600 mg daily for 14 days), a strong CYP3A inducer, resulted in 72% and 54% decreases in sonidegib AUC and Cmax respectively, compared with when sonidegib was given alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis sonidegib på 800 mg og den stærke CYP3A-induktor rifampicin (600 mg dagligt i 14 dage), at sonidegibs AUC og Cmax faldt henholdsvis 72 % og 54 % sammenlignet med administration af sonidegib alene.
English: • She must not breast-feed while taking Odomzo and for 20 months after the final dose.
Danish: • Hun må ikke amme, så længe hun tager Odomzo og i 20 måneder efter den sidste dosis.
English: Do not open, chew or crush the capsule.
Danish: Kapslen må ikke åbnes, tygges eller knuses.
English: In healthy subjects, co-administration of a single 800 mg dose of sonidegib with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A inhibitor, resulted in a 2.25-fold and a 1.49-fold increase in sonidegib AUC and Cmax, respectively, compared with sonidegib alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis sonidegib på 800 mg og den stærke CYP3A-hæmmer ketoconazol (200 mg to gange dagligt i 14 dage), at sonidegibs AUC og Cmax steg henholdsvis 2,25 og 1,49 gange sammenlignet med sonidegib alene.
English: CI: confidence interval
Danish: CI: konfidensinterval (confidence interval)
English: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Danish: Sun Pharmaceutical Industries Europe B.V.
English: • Not to donate blood during treatment and for at least 20 months after the final dose
Danish: • ikke at donere blod under behandling og i mindst 20 måneder efter sidste dosis
English: Odomzo contains lactose
Danish: Odomzo indeholder lactose
English: NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules
Danish: LÆGEMIDLETS NAVN Odomzo 200 mg hårde kapsler
English: How long to take Odomzo
Danish: Så længe skal du tage Odomzo
English: Sonidegib may pass into the semen.
Danish: Sonidegib kan udskilles i sæd.
English: • That the patient should not breastfeed during treatment and for 20 months after their final dose
Danish: • At patienten ikke må amme under behandlingen og i 20 måneder efter deres sidste dosis
English: Dose modifications* and management recommendations
Danish: Sværhedsgrad af forhøjet CK Dosisjusteringer* og behandlingsanbefalinger
English: • If CK and serum creatinine levels return to baseline consider resuming treatment at 200 mg every other day and measure CK levels weekly for 2 months and monthly thereafter; otherwise discontinue treatment permanently.
Danish: • Hvis CK- og serumkreatininværdierne vender tilbage til baseline, skal genoptagelse af behandlingen med 200 mg hver anden dag overvejes.
English: • Monitor CK and serum creatinine levels weekly until resolution to baseline.
Danish: • Monitorér CK- og serumkreatininværdierne ugentligt indtil bedring til baseline.
English: The sonidegib plasma concentration-QTc analysis showed that the upper bound of one-sided 95% confidence interval for QTc increase was below 5 msec at steady-state Cmax for 800 mg daily doses, which provide 2.3-fold plasma exposure compared with the recommended 200 mg dose.
Danish: Analyserne af sonidegib-plasmakoncentrationer i forhold til QTc viste, at den øvre grænse af 95 % konfidensintervallet for QTc-stigning var under 5 msek.
English: • If renal function is impaired, interrupt treatment and ensure that the patient is adequately hydrated and evaluate other secondary causes of renal impairment.
Danish: Sørg for, at patienten er tilstrækkeligt hydreret og evaluer andre sekundære årsager til den nedsatte nyrefunktion.
English: • Diaphragm (with spermicide, if available)
Danish: • Pessar (så vidt muligt med spermicid)
English: Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Danish: 4.4 og 4.6).
English: • Remind patients not to donate blood during treatment and for at least 20 months after final dose
Danish: • Påmind patienter om, ikke at donere blod under behandling og i mindst 20 måneder efter sidste dosis
English: The healthcare professional's reminder card should contain the following key elements:
Danish: Informationskortet til læger skal indeholde følgende vigtige informationer:
English: Odomzo may cause your baby to have severe birth defects or lead to the death of your unborn baby.
Danish: Odomzo kan give alvorlige fosterskader eller være livsfarligt for det ufødte barn.
English: How Odomzo works
Danish: Sådan virker Odomzo
English: • Interrupt treatment and monitor CK levels weekly until resolution to baseline level.
Danish: • Afbryd behandlingen og monitorér CKværdierne ugentligt indtil bedring til baseline-niveau.
English: Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see sections 4.4 and 4.6).
Danish: Fertile kvinder, som ikke overholder Odomzos program for svangerskabsforbyggelse (se pkt.
English: • Healthcare professional educational material
Danish: • Uddannelsesmateriale til læger
English: The primary efficacy endpoint of the study was objective response rate according to modified Response Evaluation Criteria in Solid Tumours (mRECIST) in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Danish: Solid Tumours (mRECIST) hos patienter med laBCC og RECIST 1.1 hos patienter med mBCC bestemt ved central vurdering.
English: How to take Odomzo
Danish: Sådan skal du tage Odomzo
English: For men
Danish: Til mænd
English: • Interrupt treatment and monitor CK levels weekly until resolution to baseline.
Danish: • Afbryd behandlingen og monitorér CKværdierne ugentligt indtil bedring til baseline.
English: Sonidegib exhibited dose-proportional increases in AUC and Cmax over the dose range from 100 mg to 400 mg, but less than dose-proportional increases above 400 mg.
Danish: Sonidegib udviser dosisproportionale stigninger i AUC og Cmax over dosisområdet 100 mg til 400 mg, men mindre end dosisproportionale stigninger over 400 mg. Der var ingen evidens for ændringer i clearance ved gentagen dosering, baseret på den farmakokinetiske populationsanalyse, og den estimerede akkumulering ved steady state var 19 gange uanset dosis.
English: Iron oxide black (E172) Propylene glycol (E1520) Shellac
Danish: Propylenglycol (E1520)
English: What Odomzo contains
Danish: Odomzo indeholder:
English: • Product information
Danish: • Produktresumé
English: • That the patient should not donate blood during treatment and for at least 20 months after their final dose
Danish: • At patienter ikke må donere blod under behandling og i mindst 20 måneder efter deres sidste dosis
English: What Odomzo is and what it is used for What you need to know before you take Odomzo How to take Odomzo
Danish: Det skal du vide, før du begynder at tage Odomzo Sådan skal du tage Odomzo Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg capsules Sonidegib
Danish: LÆGEMIDLETS NAVN Odomzo 200 mg kapsler sonidegib
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I Produktresumé, pkt.
English: • She must use 2 methods of recommended contraception (see the “Contraception” section below and section 4.6) while she is taking Odomzo, unless she commits to not having sexual intercourse (abstinence).
Danish: 4.6), mens hun tager Odomzo, medmindre hun forpligter sig til ikke at have samleje (afholdenhed).
English: Printing ink
Danish: Natriumlaurylsulfat
English: Musculoskeletal pain
Danish: Mave-tarm-kanalen Kvalme
English: Sun Pharmaceutical Industries Europe B.V. Puh/Tel: +31 23 568 55 01
Danish: Puh/Tel: +31 23 568 55 01
English: NAME OF THE MEDICINAL PRODUCT Odomzo 200 mg hard capsules Sonidegib
Danish: LÆGEMIDLETS NAVN Odomzo 200 mg hårde kapsler sonidegib
English: Lymphocyte count decreased
Danish: Nedsat lymfocyttal
English: Ranbaxy Italia S.p.A. Tel: +39 02 33 49 07 93
Danish: Tel: +39 02 33 49 07 93
English: Musculoskeletal and connective tissue disorders Muscle spasms
Danish: Knogler, led, muskler og bindevæv Muskelkramper
English: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Danish: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V.
English: • weight loss.
Danish: • vægttab.
English: Sun Pharmaceutical Industries Europe B.V. Tlf: +31 23 568 55 01
Danish: Tlf: +31 23 568 55 01
English: If you take more Odomzo than you should
Danish: Hvis du har taget for meget Odomzo
English: • Patient reminder card
Danish: • Et patientkort
English: • Patient Reminder Card
Danish: • Informationskort til patienter
English: Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Danish: Tél/Tel: +31 23 568 55 01
English: Sun Pharmaceutical Industries Europe B.V. Τηλ: +31 23 568 55 01
Danish: Τηλ: +31 23 568 55 01
English: Sun Pharmaceutical Industries Europe B.V. Sími: +31 23 568 55 01
Danish: Sími: +31 23 568 55 01
English: • a diaphragm (with spermicide, if available).
Danish: • pessar (så vidt muligt med sæddræbende creme).
English: Sun Pharmaceutical Industries Europe B.V. Тел: +31 23 568 55 01
Danish: Тел: +31 23 568 55 01
English: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V. Tél/Tel: +31 23 568 55 01
Danish: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V.
English: Date of first authorisation: 15 November 2013 Date of latest renewal: 27 August 2018
Danish: Dato for første markedsføringstilladelse: 15. november 2013 Dato for seneste fornyelse: 27. august 2018
English: Patients should be closely monitored throughout this period.
Danish: Patienterne skal overvåges nøje i denne periode.
English: Avoid use
Danish: Undgå brug
English: Do not stop your treatment just because you feel better.
Danish: Du må ikke stoppe med at få behandlingen, fordi du har fået det bedre.
English: • prolonged and/or painful erection
Danish: • Forlænget og/eller smertefuld erektion
English: The US Product Information already mentions a class warning for antipsychotics since 2017.
Danish: Den amerikanske produktinformation har siden 2017 haft en klasse-advarsel for antipsykotika.
English: They usually affect the face and mouth first but can affect other parts of the body.
Danish: Det rammer normalt først ansigtet og munden, men andre kropsdele kan også blive ramt.
English: Engage the needle safety device as described in Step 2 e).
Danish: Aktivér sikkerhedsmekanismen som beskrevet i trin 2 e).
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C.
Danish: Der er påvist kemisk og fysisk brugsstabilitet i 4 timer ved temperaturer på 25 °C.
English: The possibility of multiple medicinal product involvement should be considered.
Danish: Muligheden for, at flere lægemidler kan være involveret, skal overvejes.
English: Oral formulation should be preferred (see section 5.2).
Danish: Den oral formulering bør foretrækkes (se pkt.
English: The 518 events included 291 serious events of which 31 events were fatal.
Danish: De 518 tilfælde omfattede 291 alvorlige tilfælde, hvoraf 31 var fatale.
English: a Data were analysed using a mixed model repeated measures (MMRM) approach.
Danish: a Data blev analyseret ved hjælp af en MMRM-metode (mixed model repeated measures).
English: Increased mortality
Danish: Øget mortalitet
English: Male patients generally had a higher incidence than female patients in each treatment group.
Danish: Incidensen var generelt højere hos mandlige patienter end hos kvindelige patienter i alle behandlingsgrupper.
English: In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
Danish: Hos patienter med svært nedsat leverfunktion er de tilgængelige data ikke tilstrækkelige til at fastlægge anbefalinger.
English: All the other formulations only state in section 4.8 that dystonia is a class effect of this medication.
Danish: 4.8 for alle andre formuleringer nævnes det blot, at dystoni er en klasseeffekt ved dette lægemiddel.
English: a: Negative change in score indicates improvement.
Danish: Ikke relevant a: Negativ ændring i scoren indikerer forbedring.
English: There are a further 154 cumulative spontaneous reports of eye movement disorder, of which 22 were serious.
Danish: Der var yderligere 154 kumulative spontane indberetninger af øjenbevægelsesforstyrrelser, hvoraf 22 var alvorlige.
English: • increased sexual interest
Danish: • Øget seksuel interesse
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Danish: Disse symptomer kan midlertidigt forværres eller opstå efter afslutningen af behandlingen.
English: • liver function tests may show abnormal results
Danish: • Leverfunktionstest kan vise unormale resultater
English: Component of a multipack, can't be sold separately.
Danish: Indgår i multipakning - må ikke sælges separat.
English: • dementia (loss of memory and other mental abilities) especially if you are elderly
Danish: • har demens (hukommelsestab og tab af andre mentale evner), især hvis du er ældre
English: The majority were mild and improved on subsequent injections.
Danish: De fleste var lette og fortog sig ved de efterfølgende injektioner.
English: Tell your doctor immediately if you have any of the following serious side effects:
Danish: Fortæl det straks til lægen, hvis du får nogen af følgende alvorlige bivirkninger:
English: P-value Treatment differenceb (95 % CI)
Danish: p-værdi Behandlingsforskelb (95 % KI)
English: • medicines that are known to prolong QT prolongation.
Danish: • lægemidler, der er kendt for at forlænge QT-intervallet.
English: • inability to have or maintain an erection during sexual intercourse
Danish: • Manglende evne til at få eller fastholde en erektion under samleje
English: • decreased or increased appetite
Danish: • Øget eller nedsat appetit
English: Personal and social functioning were evaluated using the Personal and Social Performance (PSP) scale.
Danish: Den personlige og sociale funktionsevne blev evalueret ved hjælp af PSP-skalaen (Personal and Social Performance).
English: • inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Danish: • Manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte:
English: NMS is a potentially fatal symptom complex associated with antipsychotics.
Danish: NMS er et potentielt dødeligt symptomkompleks, der er forbundet med antipsykotika.
English: It should only be administered by a healthcare professional.
Danish: Dette lægemiddel må kun administreres af en sundhedsperson.
English: Single package containing:
Danish: Enkeltpakning, der indeholder:
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Danish: Hvis præparatet ikke anvendes med det samme, er opbevaringstiden under anvendelse og opbevaringsbetingelserne før anvendelse brugerens ansvar.
English: • fixation of the eyeballs in one position
Danish: • Fiksering af øjenæblerne i en fast position
English: DK 2500 Valby Denmark
Danish: DK-2500 Valby Danmark
English: Days from Randomization
Danish: Dage fra randomisering
English: • weakness, loss of strength or extreme tiredness
Danish: • Svaghed, tab af styrke eller ekstrem træthed
English: Three hypodermic safety needles
Danish: Tre hypodermiske sikkerhedskanyler
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known (frequency cannot be estimated from the available data):
Danish: Følgende bivirkninger er rapporteret efter markedsføringen af oralt aripiprazol, men hyppigheden kendes ikke (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: In this section, there is no mention of eye movement disorders.
Danish: Der nævnes ikke noget om øjenbevægelsesforstyrrelser i dette punkt.
English: • increased levels of insulin, a hormone regulating blood sugar levels
Danish: • Forhøjet niveau af insulin, et hormon, der regulerer blodsukkeret
English: Therefore, cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Danish: Kardiovaskulær monitorering skal derfor straks iværksættes og skal omfatte kontinuerlig elektrokardiografisk monitorering for mulige arytmier.
English: • jaundice (yellowing of the skin and white part of eyes)
Danish: • Gulsot (gulfarvning af huden og den hvide del af øjnene)
English: The table is based on adverse reactions reported during clinical trials and/or post-marketing use.
Danish: Tabellen er baseret på bivirkninger rapporteret under kliniske studier og/eller efter markedsføringen.
English: Do not touch the spike tip of the adapter at any time.
Danish: Du må på intet tidspunkt røre ved adapterens spids.
English: • suicide attempt and suicide
Danish: • Selvmordsforsøg og selvmord
English: It is especially important to mention the following to your doctor:
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du får følgende:
English: • allergic reactions (hypersensitivity)
Danish: • Allergisk reaktion (overfølsomhed)
English: The highest non-tumorigenic exposure in female rats was approximately 7 times the human exposure at the recommended dose.
Danish: Den højeste ikke-tumorfremkaldende eksponering hos hunrotter var ca. 7 gange den humane eksponering ved den anbefalede dosis.
English: The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
Danish: Injektionen skal administreres snarest muligt, og derefter skal den månedlige injektion genoptages.
English: There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede studier af brug af aripiprazol til gravide kvinder.
English: Nevertheless, there were differences from what has been observed with maintenance use in the treatment of schizophrenia.
Danish: Ikke desto mindre var der forskelle i forhold til observationerne ved vedligeholdelsesbehandling af skizofreni.
English: Fall: Although the available data did not provide sufficient evidence to support a clear causal relationship between aripiprazole and this ADR, 507 cases have been identified reporting 518 events of Fall associated with Abilify.
Danish: Fald: Selvom de tilgængelige data ikke gav tilstrækkelig evidens til at støtte en klar årsagssammenhæng mellem aripiprazol og denne bivirkning, er der identificeret 507 indberetninger med i alt 518 tilfælde af fald, som er forbundet med Abilify.
English: You may feel a little pain during the injection.
Danish: Det kan godt gøre en lille smule ondt, når det injiceres.
English: Solvent: clear solution
Danish: Solvens: Klar opløsning
English: While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Danish: Disse symptomer kan opstå ved lave doser, men ses med større hyppighed og med øget sværhedsgrad ved højpotente og ved større doser af første generations antipsykotika.
English: Consequently, new-born infants should be monitored carefully (see section 4.8).
Danish: Derfor skal nyfødte overvåges nøje (se pkt.
English: The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours.
Danish: PSP er en valideret kliniker-bedømt skala, der måler den personlige og sociale funktionsevne på fire områder: socialt nyttige aktiviteter (f.eks. arbejde og studier), personlige og sociale relationer, egenomsorg samt forstyrrende og aggressiv adfærd.
English: • distortion of the senses of taste and smell
Danish: • Forvrænget smags- og lugtesans
English: The suspension should be injected immediately after reconstitution.
Danish: Suspensionen skal injiceres straks efter rekonstitution.
English: Absorption of aripiprazole from the IM depot formulation was complete relative to the IM standard (immediate-release) formulation.
Danish: Absorptionen af aripiprazol fra den intramuskulære depotformulering var fuldstændig i forhold til den intramuskulære standardformulering (umiddelbar frigivelse).
English: If your baby develops any of these symptoms you need to contact your doctor.
Danish: Hvis dit barn udvikler nogen af disse symptomer, skal du kontakte lægen.
English: • swelling of hands, ankles or feet
Danish: • Hævede hænder, ankler eller fødder