FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that delamanid is administered by directly observed therapy (DOT).
Danish: Det anbefales, at delamanid administreres ved direkte observeret behandling (”directly observed therapy”, herefter forkortet DOT).
English: Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: hver filmovertrukket tablet indeholder 100 mg laktose (som monohydrat).
English: In order to further characterise the PK/PD relationship of delamanid, the MAH should conduct and submit the results of an in vitro study using the HFS-TB model.
Danish: Indehaveren af markedsføringstilladelsen skal med henblik på yderligere at karakterisere PK/PD-forholdet for delamanid gennemføre og indsende resultaterne af en in vitro-undersøgelse ved hjælp af HFS-TB-modellen.
English: • Increase in immature red blood cells
Danish: • Forøgelse af antallet af umodne røde blodceller
English: • Risk of QT interval prolongation
Danish: • Risiko for forlængelse af QT-interval
English: - Taking medicinal products that are known to prolong the QTc interval.
Danish: - Indtagelse af medicin, der vides at forlænge QTc-intervallet.
English: The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial cell wall components, methoxy-mycolic and keto-mycolic acid.
Danish: Delamanids farmakologiske virkningsmekanisme hæmmer mykobakteriernes cellevægssyntese, syntesen af methoxy-mycol- og keto-mycolsyre.
English: There are no data on the use of delamanid in patients with severe renal impairment and its use is not recommended (see sections 4.4 and 5.2).
Danish: Der foreligger ingen data om brugen af delamanid hos patienter med svær nedsat nyrefunktion, og dets brug anbefales ikke (se pkt.
English: Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (type A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate
Danish: Tabletkernen Hypromellose phthalat Povidone all-rac-α-Tocopherol Cellulose, mikrokrystallinsk Natriumstivelse glykolat (type A) Carmellose calcium Kiselsyre, kolliodal hydreret Magnesiumstearat Laktose monohydrat
English: There are also links to other websites about rare diseases and treatments.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.
English: Deltyba had no effect on male or female fertility in animals (see section 5.3).
Danish: Deltyba havde ingen virkning på hanners og hunners fertilitet hos dyr (se pkt.
English: • Increase of blood pressure (hypertension)
Danish: • Højere blodtryk (hypertension)
English: In patients receiving 200 mg delamanid total daily dose in the phase 2 and 3 trials, the mean placebo corrected increase in QTcF from baseline ranged from 4.7 - 7.6 ms at 1 month and 5.3 ms - 12.1 ms at 2 months, respectively.
Danish: Hos patienter, der fik en samlet daglig dosis på 200 mg delamanid i fase 2- og fase 3-forsøg, var den gennemsnitlige placebo-korrigerede stigning i QTcF fra baseline hhv. 4,7-7,6 ms efter 1 måned og 5,312,1 ms efter 2 måneder.
English: • Neurosis
Danish: • Neurose
English: Feeling hot
Danish: Fornemmelse af varme
English: These include (but are not limited to): - Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Danish: Herunder (men ikke udelukkende): - Anti-arytmika (f.eks. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
English: • Adjustment disorder with depressed mood
Danish: • Tilpasningsforstyrrelse med nedtrykthed
English: It is not known if delamanid passes into breast milk in humans.
Danish: Det vides ikke, om delamanid udskilles i modermælken hos mennesker.
English: All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use.
Danish: Samtidig administration af delamanid med quinoloner Alle QTcF-forlængelser over 60 ms blev sat i forbindelse med samtidig brug af fluoroquinoloner.
English: The incidence of a QTcF interval > 500 ms ranged from 0.6% (1/161) - 2.1% (7/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 1.2% (2/170) of patients receiving placebo + OBR, while the incidence of QTcF change from baseline > 60ms ranged from 3.1% (5/161) - 10.3% (35/341) in patients receiving delamanid 200 mg total daily dose versus 0% (0/160) - 7.1% (12/170) in patients receiving placebo.
Danish: Forekomsten af et QTcF-interval > 500 ms var fra 0,6 % (1/161) til 2,1 % (7/341) hos de patienter, der fik en samlet daglig dosis på 200 mg delamanid, versus 0 % (0/160) til 1,2 % (2/170) hos de patienter, der fik placebo + OBR, mens forekomsten af en QTcF-ændring fra baseline > 60 ms var fra 3,1 % (5/161) til 10,3 % (35/341) hos de patienter, der fik en samlet daglig dosis på 200 mg delamanid, versus 0 % (0/160) til 12/170) hos de patienter, der fik placebo.
English: Table: Adverse drug reactions to delamanid System Organ
Danish: Tabel: Bivirkninger ved delamanid Systemorganklasse
English: Resistance to delamanid has been documented to occur during treatment (see section 4.4).
Danish: Resistens over for delamanid er dokumenteret under behandling (se pkt.
English: Since both medications are known to prolong the QT interval, the MAH is asked to update the SmPC and PL of delamanid to list bedaquiline as one of the concomitant drugs known to prolong the QTc interval.
Danish: Da det er dokumenteret, at begge lægemidler giver forlænget QT-interval, er indehaveren af markedsføringstilladelsen blevet bedt om at opdatere produktresuméet og indlægssedlen for delamanid, så bedaquilin kommer med på listen over samtidige lægemider, der medfører forlænget QTc-interval.
English: • Foot, leg or ankle swelling
Danish: • Hævede fødder, ben eller ankler
English: The complete metabolic profile and mode of elimination of delamanid has not yet been fully elucidated (see sections 4.4 and 5.2)
Danish: Den fuldstændige metaboliske profil og elimineringsvej for delamanid er endnu ikke helt klarlagt (se pkt.
English: No clinically relevant reduction in delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg daily for 10 days in combination with delamanid 100 mg twice daily.
Danish: Der blev ikke observeret klinisk relevant reduktion i eksponeringen for delamanid sammen med den svage fremkalder efavirenz ved administration af en dosis på 600 mg dagligt i kombination med delamanid 100 mg to gange dagligt.
English: Effects of other medicinal products on Deltyba
Danish: Andre lægemidlers virkning på Deltyba
English: Available pharmacokinetic data in animals have shown excretion of delamanid and/or its metabolites in milk.
Danish: Tilgængelige farmakokinetiske data hos dyr har vist udskillelse af delamanid og/eller dets metabolitter i mælk.
English: Anti-Tuberculosis medicines
Danish: Tuberkulosemedicin
English: Delamanid has been evaluated in two, double-blind, placebo controlled trials for the treatment of MDR TB.
Danish: Delamanid er blevet undersøgt i to dobbeltblindede, placebokontrollerede forsøg vedrørende behandling af multiresistent tuberkulose (MDR TB).
English: If you stop taking Deltyba
Danish: Hvis du holder op med at tage Deltyba
English: If you forget to take Deltyba
Danish: Hvis du har glemt at tage Deltyba
English: * The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the placebo plus OBR group.
Danish: Blodtryk forhøjet * Hyppigheden for disse bivirkninger var lavere for gruppen, der fik kombineret delamanid plus OBR i forhold til den gruppe, der fik placebo plus OBR.
English: • Increased values for blood investigations for the hormone cortisol
Danish: • Forhøjede værdier for blodundersøgelser for hormonet kortisol
English: - One film-coated tablet contains 50 mg of the active substance delamanid.
Danish: - Én filmovertrukket tablet indeholder 50 mg af det aktive stof delamanid.
English: • Dry throat
Danish: • Tør hals
English: Stopping too early could allow the bacteria to recover and to become resistant to delamanid.
Danish: Hvis du stppper for tidligt med at tage tabletterne kan bakterierne blive resistente over for delamanid.
English: Elderly patients (> 65 years of age)
Danish: Ældre patienter (> 65 år) Der foreligger ikke data for ældre.
English: In the first trial (Trial 204), 64/141 (45.4%) patients randomised to receive delamanid 100 mg BID + OBR and 37/125 (29.6%) of patients randomised to receive placebo (PLC) + OBR achieved two-month sputum culture conversion (SCC) (i.e. growth of Mycobacterium tuberculosis to no growth over the first 2 months and maintained for 1 more month) (p=0.0083).
Danish: I det første forsøg (forsøg 204) opnåede 64/141 (45,4 %) patienter, der var randomiseret til at få 100 mg delamanid to gange dagligt + OBR, og 37/125 (29,6 %) patienter, der var randomiseret til at få placebo + OBR, to måneders sputumkultur-konvertering (SCC) (dvs. fra vækst af Mycobacterium tuberculosis til ingen vækst i løbet af de første 2 måneder og fastholdelse i 1 måned mere) (p = 0,0083).
English: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Danish: Deltyba er indiceret til brug som en del af en passende kombinationsbehandlingsplan for pulmonal multiresistent tuberkulose (MRD-TB) hos voksne patienter, hvor en effektiv behandling ellers ikke kan sammensættes på grund af resistens eller tolerabilitet (se pkt.
English: Frequency common
Danish: Hyppighed almindelig
English: Therefore if coadministration is considered to be unavoidable in order to construct an adequate treatment regimen for MDRTB it is recommended that there is very frequent monitoring of ECGs throughout the full delamanid treatment period.
Danish: Hvis samtidig administration derfor anses for uundgåelig for at sammensætte en tilstrækkelig behandling af MDR-TB, anbefales det at udføre hyppig overvågning af EKG under hele behandlingsperioden med delamanid.
English: Neurosis
Danish: Neuroser
English: Atrioventricular block first degree Ventricular extrasystoles* Supraventricular extrasystoles
Danish: Ventrikulære ekstrasystoler* Supraventrikulære ekstrasystoler
English: • Low blood platelets count (thrombocytopaenia)
Danish: • Lavt antal blodplader (trombocytopeni)
English: • Decreased values for blood investigations for the hormone cortisol
Danish: • Reducerede værdier for blodundersøgelser for hormonet kortisol
English: Tell your doctor... - if you are taking, have recently taken or might take any other medicines, including medicines or herbal remedies obtained without prescription, - if you are taking medicines to treat an abnormal heart rhythm (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Danish: Fortæl lægen, - hvis du bruger anden medicin eller har gjort det for nylig, eller hvis du eventuelt tager anden medicin, herunder medicin eller naturlægemidler, der er købt uden recept, - hvis du tager medicin til behandling af unormal hjerterytme (f.eks. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
English: • Low white blood cell count (leukopenia)
Danish: • Lavt antal hvide blodceller (leukopeni)
English: Eye disorders Conjunctivitis allergic*
Danish: Allergisk konjunctivitis*
English: Pharmacokinetic data in animals have shown excretion of delamanid /metabolites into breast milk.
Danish: Farmakokinetiske data hos dyr har vist udskillelse af delamanid/metabolitter i modermælk.
English: - The other ingredients are hypromellose phthalate, povidone, all-rac-α-tocopherol, microcrystalline cellulose, sodium starch glycolate, carmellose calcium, colloidal hydrated silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).
Danish: - Øvrige indholdsstoffer: hypromellose phthalat, povidone, all-rac-α-tocopherol, mikrokrystallinsk cellulose, natrium stivelsesglykolat, carmellose calcium, colloidal hydreret kiselsyre, magnesium stearat, laktose monohydrat, hypromellose, makrogol 8000, titaniumdioxid, talkum, jernoxid (E172).
English: Rash pruritic* Pruritus*
Danish: Pruritisk udslæt* Pruritus*
English: • Low blood calcium level
Danish: • Lavt kalciumniveau i blodet
English: In the second trial (Trial 213), delamanid was administered orally at 100 mg BID as an add-on therapy to an OBR for 2 months followed by 200 mg once daily for 4 months.
Danish: I det andet forsøg (forsøg 213) blev delamanid administreret oralt i en dosis på 100 mg to gange dagligt som tillægsbehandling til OBR i to måneder efterfulgt af en dosis på 200 mg én gang dagligt i fire måneder.
English: Blood cortisol decreased
Danish: Blodkortisol reduceret
English: Therefore if co-administration of delamanid with any strong inhibitor of CYP3A4 is considered necessary it is recommended that there is very frequent monitoring of ECGs, throughout the full delamanid treatment period.
Danish: Hvis samtidig administration af delamanid og en kraftig CYP3A4-hæmmer anses for nødvendig, anbefales det derfor, at der udføres hyppig overvågning af EKG under hele behandlingsperioden med delamanid.
English: Co-administration of delamanid with a strong inhibitor of CYP3A4 (lopinavir/ritonavir) was associated with a 30% higher exposure to the metabolite DM-6705, which has been associated with QTc prolongation.
Danish: Samtidig administration of kraftige CYP3A4-hæmmere Samtidig administration af delamanid og en kraftig CYP3A4-hæmmer (lopinavir/ritonavir) blev sat i forbindelse med 30 % højere eksponering for metabolitten DM-6705, der er sat i forbindelse med QTc-forlængelse.
English: Clinical drug-drug interactions studies in healthy subjects indicated a reduced exposure to delamanid, of up to 45% following 15 days of concomitant administration of the strong inducer of cytochrome P450 (CYP) 3A4 (Rifampicin 300 mg daily) with delamanid (200 mg daily).
Danish: Kliniske interaktionsforsøg hos raske forsøgspersoner indicerede en reduceret eksponering for delamanid med indtil 45 % efter 15 dages samtidig administration af den stærke fremkalder af cytokrom P450 (CYP) 3A4 (rifampicin 300 mg dagligt) sammen med delamanid (200 mg dagligt).
English: Dysphoria
Danish: Dyspnø
English: • Tenderness in the abdomen
Danish: Ømhed i abdomen*
English: Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) (see sections 4.4 and 5.1).
Danish: Delamanid skal altid gives som en del af en hensigtsmæssig behandling af multiresistent tuberkulose (MDRTB) (se pkt.
English: - Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
Danish: - Neuroleptika (f.eks. phenothiaziner, sertindole, sultopride, klorpromazine, haloperidol, mesoridazine, pimozide eller thioridazine), antidepressiva.
English: Dizziness* Headache Paraesthesia Tremor
Danish: Svimmelhed* Hovedpine Paræstesi Tremor
English: Delamanid is not recommended in patients with moderate to severe hepatic impairment.
Danish: Delamanid anbefales ikke til patienter med moderat til svær leversvækkelse.
English: Each film-coated tablet contains: 50 mg delamanid
Danish: Hver filmovertrukket tablet indeholder: 50 mg delamanid
English: - if you are taking medicines to treat psychoses (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression - if you are taking certain antimicrobial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
Danish: - hvis du tager medicin til behandling af psykoser (f.eks. phenothiaziner, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide eller thioridazine) eller depression - hvis du tager visse antimikrobielle lægemidler (f.eks. erytromycin, claritromycin, moxifloxacin, sparfloxacin, bedaquilin eller pentamidin).
English: Hypertension Hypotension Haematoma* Hot flush*
Danish: Hypertension Hypotension Hæmatoma* Hedestigning*
English: Deltyba 50 mg film-coated tablets delamanid
Danish: Deltyba 50 mg filmovertrukne tabletter delamanid
English: The PRAC noted the recurrent concomitant use of delamanid with bedaquiline in patients experiencing QTc prolongation.
Danish: PRAC bemærkede, at patienter, der regelmæssigt anvendte delamanid og bedaquilin samtidigt, oplevede QTc-forlængelse.
English: Patients with hepatic impairment
Danish: Patienter med nedsat leverfunktione
English: Each film-coated tablet contains 50 mg delamanid.
Danish: Hver filmovertrukket tablet indeholder 50 mg delamanid.
English: ECG QT interval prolongation
Danish: EKG QT-intervalforlængelse
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: Other medicines and Deltyba
Danish: Brug af anden medicin sammen med Deltyba
English: • Feeling hot
Danish: • Fornemmelse af varme
English: • Problems with sleeping
Danish: • Søvnproblemer
English: Depression and depressed mood
Danish: Ængstelse og angst Depression og nedtrykt tilstand
English: In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (200 mg daily) and with rifampicin/isoniazid/pyrazinamide (300/720/1800 mg daily) or ethambutol (1100 mg daily) for 15 days.
Danish: I et klinisk lægemiddelinteraktionsforsøg hos raske forsøgspersoner blev delamanid administreret alene (200 mg dagligt) og sammen med rifampicin/isoniazid/pyrazinamide (300/720/1800 mg dagligt) eller ethambutol (1100 mg dagligt i 15 dage.
English: • Psychotic disorder
Danish: • Psykotisk forstyrrelse
English: Trial 204 and 2 of 511 patients in Trial 213 (4 of 827 patients [0.48%]).
Danish: Resistens over for delamanid (defineret som MIC ≥ 0,2 µg/ml) er observeret ved baseline hos 2 ud af 316 patienter i forsøg 204 og 2 ud af 511 patienter i forsøg 213 (4 ud af 827 patienter [0,48 %]).
English: Deltyba 50 mg film-coated tablets
Danish: Deltyba 50 mg filmovertrukne tabletter
English: Therefore no dose adjustment is needed for patients with mild or moderate renal impairment.
Danish: Der kræves derfor ingen dosisjustering for patienter med mild eller moderat nyresvækkelse.
English: Contents of the pack and other information What Deltyba contains
Danish: Pakningsstørrelser og yderligere oplysninger Deltyba indeholder:
English: - if you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine) - if you are taking any of the following: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), diphemanil (used to treat stomach disorders or excessive sweating), probucol (lowers the level of cholesterol in the bloodstream), levomethadyl or methadone (used for the treatment of opiate addiction), vinca alkaloids (anti-cancer medicines), or arsenic trioxide (used to treat certain types of leukaemia).
Danish: - hvis du tager et eller flere af følgende midler: cisapride (anvendes til at behandle mavesygdomme), droperidol (bruges mod opkastning og migræne), domperidone (bruges mod kvalme og opkastning bepridil (bruges til behandling af visse hjertesygdomme), diphemanil (bruges til behandling af mavesygdomme eller overdreven sveddannelse), probucol (sænker kolesterolindholdet i blodet), levomethadyl eller methadone (bruges til behandling af afhængighed af opiater), vinca alkaloids (kræftmedicin), eller arsenisk trioxid (bruges til behandling af visse typer leukæmi).
English: Short title: OTSUKA
Danish: : OTSUKA
English: Oropharyngeal pain Throat irritation Dry throat* Rhinorrhoea*
Danish: Oropharyngeal smerte Halsirritation Tør hals*
English: Mental disorder
Danish: Psykiske forstyrrelser
English: • Joint or muscle pain
Danish: • Led- eller muskelsmerter
English: Psychotic disorder Agitation
Danish: Psykotisk sygdom Ophidselse
English: Constipation* Abdominal pain Abdominal pain lower Dyspepsia
Danish: Konstipation* Mavesmerter Smerter i nederste del af maveregionen Dyspepsi
English: • High blood cholesterol level
Danish: • Højt kolesteroltal
English: • Swallowing problems
Danish: • Fordøjelsesproblemer
English: Hepatic impairment Deltyba is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and
Danish: Nedsat leverfunktion Deltyba anbefales ikke til patienter med moderat til svær leversvækkelse (se pkt.
English: • Drug use during breast feeding.
Danish: • Anvendelse af lægemidlet under amning.
English: Osteochondrosis Muscular weakness Musculoskeletal pain* Flank pain
Danish: Osteokrondrose Muskelsvækkelse Smerter i muskler/knogler* Flankesmerter Smerter i ekstremiteter
English: If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital.
Danish: Kontakt lægen eller det lokale hospital, hvis du har taget flere tabletter end din ordinerede dosis.
English: • Drug- resistance
Danish: • Lægemiddelresistens
English: Mild renal impairment (50 mL/min < CrCLN < 80 mL/min) does not appear to affect delamanid exposure.
Danish: <CrCLN < 80 ml/min.)
English: Side effects very commonly reported in clinical studies with Deltyba were:
Danish: Bivirkninger, der indberettes som meget almindelige i kliniske forsøg med Deltyba:
English: How to take Deltyba
Danish: Sådan skal du tage Deltyba
English: Oral use
Danish: Peroral anvendelse
English: Method of administration For oral use.
Danish: Til peroral anvendelse.
English: Haematuria*
Danish: Hæmaturia*
English: In clinical drug-drug interaction studies in healthy subjects, delamanid was administered alone (100 mg twice daily) and with tenofovir disoproxil (245 mg daily) or lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Danish: I kliniske interaktionsforsøg hos raske forsøgspersoner blev delamanid administreret alene (100 mg to gange dagligt) og sammen med tenofovirdisoproxil (245 mg dagligt) eller lopinavir/ritonavir (400/100 mg dagligt) i 14 dage og sammen med efavirenz i 10 dage (600 mg dagligt).
English: • Increased blood uric acid level
Danish: • Øget urinsyreindhold i blodet
English: In a clinical drug-drug interaction study in healthy subjects, delamanid was administred alone (100 mg twice daily) and tenofovir disoproxil (245 mg daily), lopinavir/ritonavir (400/100 mg daily) for 14 days and with efavirenz for 10 days (600 mg daily).
Danish: I et klinisk lægemiddelinteraktionsforsøg hos raske forsøgspersoner blev delamanid administreret alene (100 mg to gange dagligt) og sammen med tenofovirdisoproxil (245 mg dagligt), lopinavir/ritonavir (400/100 mg dagligt) i 14 dage og sammen med efavirenz i 10 dage (600 mg dagligt).
English: In mycobacteria, the in vitro frequencies of spontaneous resistance to delamanid were similar to those for isoniazid, and were higher than those for rifampicin.
Danish: For mykobakterier svarer in vitro-hyppighederne for spontan resistens over for delamanid til dem,
English: • Increased blood tryglycerides
Danish: • Forhøjede triglycerider i blodet
English: Delusional disorder, persecutory type
Danish: Vrangforestillinger, forfølgelsestypen Panisk tilstand Tilpasningstilstand med depression
English: The MAH should agree the educational material with the Member States, prior to launch.
Danish: Forud for lanceringen skal indehaveren af markedsføringstilladelsen blive enig med den pågældende medlemsstat om undervisningsmaterialet.
English: Side effects commonly reported in clinical studies with Deltyba were:
Danish: Bivirkninger, der indberettes som almindelige i kliniske forsøg med Deltyba: