FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma albumin and CYP3A4 regulate the formation and metabolism of DM-6705 respectively (see Special Considerations below).
Danish: Plasma albumin og CYP3A4 regulerer henholdsvis dannelsen og metabolismen af DM-6705 (se Særlige overvejelser nedenfor).
English: In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(pgp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of approximately 5 to 20 fold greater than the Cmax at steady state.
Danish: In-vitro forsøg har vist, at delamanid og metabolitter ikke har nogen effekt på transportørme MDR1(p-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 og BSEP ved koncentrationer på ca. 5 til 20 gange større end Cmax ved steady state.
English: It is recommended that electrocardiograms (ECG) should be obtained before initiation of treatment and monthly during the full course of treatment with delamanid.
Danish: Det anbefales, at der tages elektrokardiogram (EKG) før behandlingsstart og månedligt under hele behandlingsforløbet med delamanid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium/Aluminium
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Aluminium/Aluminium
English: Delamanid and/or its metabolites have the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Danish: Delamanid og/eller dets metabolitter har potentiale til at påvirke hjerterepolarisering via blokering af hERG-kaliumkanaler.
English: Dry eye* Photophobia
Danish: Tørre øjne* Fotofobi
English: Co-administration with delamanid significantly increased steady state plasma concentrations of ethambutol by approximately 25%, the clinical relevance is unknown.
Danish: Administration sammen med delamanid øgede signifikant steady state-plasmakoncentrationerne af ethambutol med ca. 25 %, den kliniske relevans er ukendt.
English: • Increase of libido
Danish: • Forhøjet libido
English: Delamanid is not excreted in urine.
Danish: Delamanid udskilles ikke i urin.
English: The Educational material for Healthcare Providers (HCPs) shall address the following key elements:
Danish: Undervisningsmaterialet for sundhedspersonale skal indeholde følgende centrale elementer:
English: Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.
Danish: Deltyba leveres i pakninger med 48 filmovertrukne tabletter i aluminium/aluminium blisterpakninger.
English: Exposure of concomitant anti-TB drugs (rifampicin [R]/ isoniazid [H]/ pyrazinamide [Z]) was not affected.
Danish: Eksponeringen for samtidig tuberkulosemedicin (rifampicin [R] / isoniazid [H] / pyrazinamide [Z]) blev ikke påvirket.
English: Transaminases increased* Activated partial thromboplastin time prolonged*
Danish: Aktiveret partiel tromboplastintid forlænget*
English: Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold compared to fasting conditions.
Danish: Oral biotilgængelighed for delamanid forbedres, når lægemidlet administreres med et standardmåltid, ca. 2,7 gange sammenlignet med fastende tilstand.
English: Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Danish: Behandling med delamanid skal påbegyndes og overvåges af en læge med erfaring i håndtering af multiresistent Mycobacterium tuberculosis.
English: The complete metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with other co-administered medications, if significant unknown metabolites are discovered.
Danish: Delamanids fuldstændige, metaboliske profil er endnu ikke klarlagt, og der er mulighed for lægemiddelinteraktion med andre samtidigt administrerede lægemidler, dersom der opdages signifikante, ukendte metabolitter.
English: It is not known whether delamanid and metabolites will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Det vides ikke, om delamanid og metabolitter fjernes signifikant ved hæmodialyse eller peritoneal dialyse.
English: • Abnormal blood values related to the function of the liver, biliary system or pancreas
Danish: • Unormale blodværdier vedrørende funktion af lever, galdesystem eller bugspytkirtlen
English: Delamanid resistance emerged in 4 of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213.
Danish: Resistens over for delamanid opstod hos 4 ud af 341 patienter (1,2 %), der var randomiseret til at få delamanid i 6 måneder i forsøg 213.
English: Effects of Deltyba on other medicinal products
Danish: Deltybas virkning på andre lægemidler
English: In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 7H11 medium.
Danish: I kliniske forsøg er resistens over for delamanid defineret som enhver vækst i tilstedeværelsen af en delamanidkoncentration på 0,2 µg/ml, der er større end 1 % af den, der findes i medicinfrie kontrolkulturer på Middlebrook 7H11-medie.
English: • Abnormal feeling in the mouth
Danish: • Unormal fornemmelse i munden
English: QT prolongation has been observed in patients treated with delamanid.
Danish: QT-forlængelse er observeret hos patienter behandlet med delamanid.
English: • Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet
Danish: • Nerveskade, der medfører følelsesløshed eller smerter (brændende) eller prikkende fornemmelse i hænder eller fødder
English: Delamanid does not show cross-resistance with any of the currently used anti-tuberculosis drugs.
Danish: Delamanid udviser ikke krydsresistens med nogen aktuelt anvendte lægemidler mod tuberkulose.
English: However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily.
Danish: Yderligere kliniske data viste imidlertid, at hos patienter, der modtog 200 mg to gange dagligt, dvs. i alt 400 mg delamanid pr. dag, svarer den generelle sikkerhedsprofil til den, man finder hos patienter, der modtager den anbefalede dosis på 100 mg to gange dagligt.
English: In order to further investigate the use of delamanid in different combination treatment regimens as well as safety, the MAH should submit the results of the endTB (Evaluating Newly approved Drugs for multidrug-resistant TB) study, a randomized, controlled Phase III trial in adults and adolescents with multi-drug-resistant tuberculosis conducted by Médecins Sans Frontières, including an additional analysis of the data with a focus on the evaluation of delamanid based on an agreed statistical analysis plan.
Danish: Indehaveren af markedsføringstilladelsen skal med henblik på yderligere at undersøge brugen af og sikkerheden ved delamanid i forskellige kombinationsbehandlinger indsende resultaterne af endTB (Evaluating Newly approved Drugs for multidrug-resistant TB)-studiet, der er et randomiseret, kontrolleret fase III-studie hos voksne og unge med multiresistent tuberkulose, som gennemføres af Læger Uden Grænser, herunder en ekstra analyse af data med fokus på evaluering af delamanid på grundlag af en aftalt statistisk analyseplan.
English: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen Germany
Danish: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen Tyskland
English: • Sensations of irregular and/or forceful beating of the heart
Danish: • Følelse af uregelmæssigt og/eller kraftige hjerteslag
English: • Pain in the mouth or throat
Danish: • Smerter i mund eller hals
English: • Reduced sensation
Danish: • Reduceret følelse
English: Cytochrome P450 3A4 inducers
Danish: Cytokrom P450 3A4- inducerende stoffer
English: Q4 2019
Danish: 4. kvartal 2019
English: Frequency very common
Danish: Hyppighed meget almindelig
English: Posology The recommended dose for adults is 100 mg twice daily for 24 weeks.
Danish: Dosering Den anbefalede dosis til voksne er 100 mg to gange dagligt i 24 uger.
English: Patients who commence delamanid with serum albumin <3.4 g/dL or experience a fall in serum albumin into this range during treatment should receive very frequent monitoring of ECGs throughout the full delamanid treatment period.
Danish: Patienter, der påbegynder delamanid med serum albumin < 3,4 mg/dl, eller som oplever et fald i serum albumin til dette interval under behandlingen, skal have hyppig overvågning af EKG under hele behandlingsperioden med delamanid.
English: There are no clinical data on the use of delamanid to treat - extra pulmonary tuberculosis (e.g. central nervous system, bone) - infections due to Mycobacterial species other than those of the M. tuberculosis complex - latent infection with M. tuberculosis
Danish: Der foreligger ingen kliniske data om brugen af delamanid til behandling af - ekstra-pulmonal tuberkulose (f.eks. i centralnervesystem, knogler) - infektioner, som skyldes andre mykobakteriearter end M. tuberculosis komplekset - latent infektion med M. tuberculosis.
English: • Abnormal values for blood investigations related to coagulation (prolonged APPT)
Danish: • Unormale værdier for blodundersøgelser vedrørende koagulation (forlænget APPT)
English: The list of adverse drug reactions and frequencies are based on the results from 2 double-blind placebo controlled clinical trials (delamanid plus OBR, n = 662 vs placebo plus OBR n = 330).
Danish: Listen over bivirkninger og hyppigheder er baseret på resultaterne af 2 dobbeltblindede, placebokontrollerede kliniske forsøg (delamanid + OBR, n = 662 versus placebo + OBR, n = 330).
English: Co-administration of moxifloxacin and delamanid in MDR-TB patients has not been studied.
Danish: Samtidig administration af moxifloxacin og delamanid hos MDR-TB-patienter er ikke undersøgt.
English: In rabbits reproductive studies, embryo-fetal toxicity was observed at maternally toxic dosages.
Danish: I reproduktionsstuder hos kaniner blev der observeret embryo-føtal toksicitet ved maternalt giftige doser.
English: Dehydration Hypocalcaemia Hypercholesterolaemia
Danish: Dehydrering Hypocalcæmi Hyperkolesterolæmi
English: • Pain in arms or legs
Danish: • Smerter i arme eller ben
English: The educational material for Patients to be provided via the HCPs to reinforce and supplement the information provided in the patient information leaflet.
Danish: Undervisningsmaterialet for patienter skal udleveres af sundhedspersonalet for at underbygge og supplere de oplysninger, som gives i indlægssedlen.
English: Neuropathy peripheral Somnolence* Hypoaesthesia
Danish: Perifer neuropati Somnolens* Hypoæstesi
English: Both showed a 13-day shorter median time to SCC in the delamanid + OBR group (p=0.0281 for LOCF and p=0.0052 for “bookending”).
Danish: Begge viste en 13-dage kortere median tid til SCC i delamanid+OBR-gruppen (p = 0,0281 for LOCF og p = 0,0052 for bookending).
English: Activity against specific pathogens Delamanid has no in vitro activity against bacterial species other than mycobacteria.
Danish: Aktivitet mod specifikke patogener Delamanid har ingen in vitro-aktivitet i forhold til andre bakterielle arter end mykobakterier.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har vist reproduktiv toksicitet (se pkt.
English: Titanium dioxide Talc
Danish: Titaniumdioxid Talkum
English: It is unknown whether this medicinal product or its metabolites are excreted in human milk.
Danish: Det vides ikke, om dette lægemiddel eller dets metabolitter udskilles ihuman mælk.
English: Lethargy Balance disorder Radicular pain Poor quality sleep
Danish: Balanceforstyrrelse Radikulær smerte Dårlig søvnkvalitet
English: - Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Danish: - Alle hjertesygdomme, der medfører disponering for arytmi, f.eks. svær hypertension, venstre ventrikulær hypertrofi (herunder hypertrofisk kardiomyopati) eller kongestiv hjerteinsufficiens ledsaget af reduceret venstre ventrikel ejektionsfraktion.
English: • Regional pain
Danish: • Regional smerte
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Deltyba in one or more subsets of the paediatric population in {treatment in multi-drug resistant tuberculosis} (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Deltyba i en eller flere undergrupper af den pædiatriske population med {behandling ved multiresistent tuberkulose} (se pkt.
English: Moxifloxacin is not recommended for use in patients treated with delamanid
Danish: Moxifloxacin anbefales ikke til brug hos patienter, der behandles med delamanid.
English: Such patients should receive very frequent monitoring of ECG throughout the full delamanid treatment period.
Danish: Sådanne patienter skal have meget hyppig EKG-overvågning under hele behandlingsperioden med delamanid.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke gennemført forsøg vedrørende virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: No cases of delamanid overdose have been observed in clinical trials.
Danish: Der er ikke observeret tilfælde af overdosering af delamanid i kliniske forsøg.
English: • Allergic conjunctivitis
Danish: • Allergisk konjunctivitis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR BLISTER PACKS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTONER TIL BLISTERPAKNINGER
English: - if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
Danish: - hvis du tager visse lægemidler til behandling af allergiske reaktioner (f.eks. terfenadine, astemizole, mizolastine).
English: Delamanid exposure remained unchanged (<25% difference) with anti-HIV medicines tenofovir disoproxil and efavirenz but was slightly increased with the combination anti-HIV medicine containing lopinavir/ritonavir.
Danish: Delamanid-eksponeringen forblev uændret (<25 % forskel) sammen med HIV-lægemidlerne tenofovirdisoproxil og efavirenz, men øgedes en smule med kombinationslægemidlerne mod HIV, der indeholder lopinavir/ritonavir.
English: Swallow the tablets with water.
Danish: Tabletterne sluges og indtages med vand.
English: The identified metabolites of delamanid do not show anti-mycobacterial activity.
Danish: Delamanids identificerede metabolitter viser ikke antimykobakteriel aktivitet.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD DERAF
English: Delamanid given in combination with the anti-HIV-medicines, tenofovir disoproxil, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal products.
Danish: Delamanid givet i kombination med HIV-lægemidlerne tenofovirdisoproxil, lopinavir/ritonavir og efavirenz påvirkede ikke eksponeringen for disse lægemidler.
English: Q1 2022
Danish: 1. kvartal 2022
English: There are no clinical data on the effects of delamanid on fertility in humans.
Danish: Der findes ingen kliniske data vedrørende delamanids virkning på fertiliteten hos mennesker.
English: • Yeast infection of the skin (tinea versicolor)
Danish: • Gærsvampeinfektion i huden (tinea versicolor)
English: Care must be taken in using delamanid in patients already receiving medicines associated with QT prolongation (see section 4.4).
Danish: Forsigtighed skal udvises ved brug af delamanid hos patienter, der allerede modtager medicin, der sættes i forbindelse med QT-forlængelse (se pkt.
English: In a clinical study, the presence of hypoalbuminaemia was associated with an increased risk of prolongation of the QTc interval in delamanid treated patients.
Danish: I et klinisk forsøg blev tilstedeværelsen af hypoalbuminæmi sat i forbindelse med øget risiko for forlængelse af QTc-intervallet hos patienter, der blev behandlet med delamanid.
English: Iron oxide yellow (E172)
Danish: Jernoxid gul (E172)
English: • Drug use during pregnancy • Drug use during breast feeding.
Danish: • Anvendelse af lægemidlet under graviditet • Anvendelse af lægemidlet under amning.
English: For patients receiving 100 mg delamanid + OBR twice daily, the frequency was 8.1% (frequency category common) in comparison to a frequency of 6.3% in patients receiving placebo + OBR twice daily.
Danish: For patienter, der fik 100 mg delamanid + OBR to gange dagligt var hyppigheden 8,1 % (frekvenskategori almindelig) sammenlignet med 6,3 % hos patienter, der fik placebo + OBR to gange dagligt.
English: There is evidence in the last PSUR to suspect the possibility of a causal relationship of liver disorders with delamanid, but the scientific evidence is insufficient to conclude that the association is causal.
Danish: Der er oplysninger i den seneste PSUR, som peger på en mulig årsagssammenhæng mellem leversygdom og delamanid, men der er ikke tilstrækkelig videnskabelig evidens til at fastslå en sådan årsagssammenhæng.
English: Medicinal products with the potential to prolong QTc
Danish: Lægemidler med potentiale til forlængelse af QTc.
English: Libido increased*
Danish: Øget libido*
English: - if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for delamanid eller et af de øvrige indholdsstoffer i Deltyba (angivet i pkt.
English: Delamanid must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by WHO to prevent development of resistance to delamanid.
Danish: Delamanid må kun anvendes i en passende kombinationsbehandlingsplan for MDR-TB-behandling i henhold til anbefalinger fra WHO for at forhindre udvikling af resistens over for delamanid.
English: Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required.
Danish: Behandling af overdosering bør omfatte omgående forholdsregler for at fjerne delamanid fra mavetarmkanalen og støttende behandling efter behov.
English: Delamanid is contraindicated in patients with albumin <2.8 g/dL (see section 4.3).
Danish: Delamanid er kontraindiceret for patienter med albumin <2,8 g/dl (se pkt.
English: • A bone disease called osteochondrosis
Danish: • En knoglesygdom, der kaldes osteokondrose
English: In lactating rats, the Cmax for delamanid in breast milk was 4-fold higher than that of the blood.
Danish: for delamanid i modermælk 4 gange højere end værdien i blodet.
English: There are no clinical data on the use of delamanid as part of combination regimens used to treat drug susceptible M. tuberculosis.
Danish: Der foreligger ingen kliniske data om brugen af delamanid som en del af kombinationsbehandlingsplaner, der anvendes til at behandle lægemiddelresistent M. tuberculosis.
English: • A tingling, burning or pricking sensation or numbness of the skin (paresthesia)
Danish: • En snurrende, brændende eller prikkende fornemmelse eller følelsesløshed i huden (paræsthesia)
English: Deltyba 50 mg film-coated tablets are round, and yellow.
Danish: Deltyba 50 mg filmovertrukne tabletter er runde og gule.
English: Eosinophilic pustular folliculitis* Pruritus generalised* Rash erythematous
Danish: Eosinophilic pustular folliculitis* Generel pruritus* Erytematøst udslæt
English: What you need to know before you take Deltyba Do not take Deltyba:
Danish: Det skal du vide, før du begynder at tage Deltyba Brug ikke Deltyba :
English: • Decrease of blood pressure (hypotension)
Danish: • Lavere blodtryk (hypotension)
English: The most frequently observed adverse drug reactions in patients treated with delamanid + Optimised Background Regimen (OBR) (i.e. incidence > 10%) are nausea (32,9%), vomiting (29,9%), headache (27.6%), insomnia (27.3%), dizziness (22.4%), tinnitus (16.5%), hypokalaemia (16.2%), gastritis (15.0%), decreased appetite (13.1%), and asthenia (11.3%).
Danish: De hyppigst observerede bivirkninger hos patienter, der blev behandlet med delamanid + optimeret baggrundsbehandling (Optimised Background Regimen, herefter forkortet OBR) (dvs. forekomst > 10 %) er kvalme (32,9 %), opkastning (29,9 %), hovedpine (27,6 %), søvnløshed (27,3 %), svimmelhed (22,4 %), tinnitus (16,5 %), hypokaliæmi (16,2 %), gastritis (15,0 %), nedsat appetit (13,1 %) og asteni (11,3 %).
English: Breast-feeding is not recommended during treatment with Deltyba.
Danish: Amning anbefales ikke under behandling med Deltyba.
English: Because a potential risk to the breast-feeding infant cannot be ruled out , it is recommended that women should not breastfeed during treatment with Deltyba.
Danish: Da der er en potentiel risiko for det diende barn, anbefales det, at kvinder ikke ammer under behandling med Deltyba (se pkt.
English: • Increase of certain white blood cells (eosinophilia)
Danish: • Forøgelse af antallet af visse hvide blodceller (eosinofili)
English: Repeat-dose toxicity studies in rabbits revealed an inhibitory effect of delamanid and/or its metabolites on vitamin K-dependent blood clotting.
Danish: Toksicitetsstudier med gentagne doser hos kaniner viste en hæmmende effekt for delamanid og/eller dets metabolitter på vitamin K-afhængig blodkoagulation.
English: Leukopenia Thrombocytopaenia
Danish: Leukopeni Trombocytopeni
English: Deltyba film-coated tablets contain lactose.
Danish: Deltyba filmovertrukne tabletter indeholder laktose.
English: The median time to SCC was 51 days in the delamanid + OBR group compared with 57 days in the PLC + OBR group (p = 0.0562 using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test).
Danish: Den mediane tid til SCC var 51 dage i delamanid+OBR-gruppen sammenholdt med 57 dage i placebo+OBRgruppen (p = 0,0562 ved brug af den stratificerede, modificerede Peto-Peto-modifikation af Gehan/Wilcoxon-rangsumstesten).
English: - if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
Danish: - hvis du tager svampemidler på basis af triazol (f.eks. fluconazole, itraconazole, voriconazole).
English: No studies have been performed in paediatric patients.
Danish: Pædiatrisk population Der er ikke gennemført forsøg med pædiatriske patienter.
English: Anti-HIV medicines
Danish: Lægemidler mod hiv
English: In the dog, foamy macrophages were observed in lymphoid tissue of various organs during repeat-dose toxicity studies.
Danish: Hos hunde blev der observeret skummende makrofager i lymfevævet i forskellige organer under toksicitetsstudier med gentagne doser.
English: The proportion of patients achieving SCC (sputum culture conversion) after the 6-month treatment period was 87.6% (198/226) in the delamanid + OBR treatment group compared to 86.1% (87/101) in the placebo + OBR treatment group (p=0.7131).
Danish: Andelen af patienter, der opnår SCC (sputumkultur-konvertering) efter den 6-måneder lange behandlingsperiode var 87,6 % (198/226) i delamanid+OBR-gruppen sammenholdt med 86,1 % (87/101) i placebo+OBR-gruppen (p = 0,7131).
English: • Urine retention
Danish: • Urinretention
English: Special Considerations Cardiac risk factors
Danish: Risikofaktorer for hjertet
English: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München Germany
Danish: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München Tyskland
English: • Balance disorder
Danish: • Balanceforstyrrelse
English: The time to SCC for the group randomised to 100 mg BID was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056).
Danish: Tiden til SCC for den gruppe, der var randomiseret til 100 mg to gange dagligt, var også kortere end for den gruppe, der var randomiseret til placebo + OBR (p = 0,0056).