FrancophonIA/ELRC3.0 huggingface dataset:
English: Manual stress (in-process control) and tensile strength (finished product specification) are performed on the ring during manufacture and the ring is not expected to lose its integrity after 3 weeks of use.
Maltese: Matul il-manifattura, fuq iċ-ċirku jitwettaq stress manwali (kontroll waqt ilmanifattura) u reżistenza għat-tensjoni (speċifikazzjoni tal-prodott lest), u dan mhux mistenni li jitlef l-integrità tiegħu wara 3 ġimgħat ta' użu.
English: The contraceptive effect of the vaginal delivery system is based on various mechanisms, the most important of which is the inhibition of ovulation.
Maltese: L-effett kontraċettiv tas-sistema ta' għoti vaġinali huwa bbażat fuq diversi mekkaniżmi, bl-aktar importanti jkun l-inibizzjoni tal-ovulazzjoni.
English: The Committee considered the available data submitted in support of the use of Perlinring during an extended week up to 28 days, which included in vivo-in vitro correlation, pharmaceutical data such as in vitro dissolution and residual content, and ring integrity and tolerability.
Maltese: Il-Kumitat qies id-data disponibbli, mibgħuta b'appoġġ għall-użu ta' Perlinring matul ġimgħa estiża sa massimu ta' 28 jum, li kienet tinkludi korrelazzjoni in vivo-in vitro, data farmaċewtika bħax-xoljiment in vitro u l-kontenut residwu, u lintegrità u t-tollerabbiltà taċ-ċirku.
English: Pharmaceutical equivalence of test and reference medicinal product, and comparable in vitro dissolution data evaluating the rate of release of both over 28 days has been demonstrated
Maltese: L-ekwivalenza farmaċewtika tal-prodott mediċinali tat-test u ta' referenza, u d-data dwar ixxoljiment in vitro komparabbli li tevalwa r-rata ta' rilaxx tat-tnejn li huma fuq perjodu ta' 28 jum intweriet
English: To address the issue of extended use up to 28 days, which is included in the SmPC of NuvaRing as a deviation to the recommended use, the applicant has additionally conducted IVIVC modelling to demonstrate that the behaviour of the ring does not change between 21 and 28 days, based on data from the test product for 21 days and from published data on reference product for 28 days.
Maltese: Sabiex tiġi indirizzata l-kwistjoni tal-użu estiż sa massimu ta' 28 jum, li hija inkluża fl-SmPC ta' NuvaRing bħala devjazzjoni għall-użu rakkomandat, l-applikant barra minn hekk wettaq immudellar IVIVC biex juri li l-imġiba taċ-ċirku ma tinbidilx bejn 21 u 28 jum, abbażi ta' data mill-prodott tat-test għal 21 jum u mid-data ppubblikata dwar il-prodott ta' referenza għal 28 jum.
English: The sampling period of 21 days in the conducted bioequivalence study is in line with the recommended use of the product, and it is undisputed that the evidence for bioequivalence of the test product Perlinring and the reference medicinal product NuvaRing has been adequately demonstrated for the recommended duration of use.
Maltese: Perlinring u l-prodott mediċinali ta' referenza NuvaRing intweriet b'mod adegwat għad-durata tal-użu rakkomandata.
English: ENG/EE ring is indicated for contraception and is intended for women of fertile age.
Maltese: Iċ-ċirku ENG/EE huwa indikat għall-kontraċezzjoni u huwa maħsub għal nisa ta' età fertili.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: 48 tablets
Maltese: 48 pillola
English: 80636 München Germany
Maltese: 80636 München
English: Short title: OTSUKA
Maltese: FIS-SUQ Titlu mqassar: OTSUKA
English: Deltyba contains lactose monohydrate.
Maltese: Deltyba fih lactose monohydrate.
English: Anti-HIV medicines
Maltese: Mediċini anti-HIV
English: • Paranoia
Maltese: • Paranojja
English: Herpes zoster Oropharyngeal candidiasis Tinea versicolor*
Maltese: Herpes zoster Kandidijasi orofarinġeali Tinea versicolor*
English: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen Germany
Maltese: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen
English: Paraesthesia oral Abdominal tenderness*
Maltese: Paraestesja orali Tenerezza addominali*
English: Cytochrome P450 3A4 inducers
Maltese: Indutturi ta' cytochrome P450 3A4
English: Film coating Hypromellose Macrogol 8000
Maltese: Il-kisi tal-pillola Hypromellose Macrogol 8000
English: Anaemia* Eosinophilia*
Maltese: Anemija* Eosinofilja*
English: Rash maculo-papular* Rash*
Maltese: Raxx makulo-papulari* Raxx*
English: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München Germany
Maltese: Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München
English: - Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Maltese: Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, alkalojdi ta' vinca, arsenic trioxide.
English: Elimination Delamanid disappears from plasma with a t1/2 of 30-38 hours.
Maltese: Eliminazzjoni Delamanid jisparixxi mill-plażma b' t1/2 of 30-38 siegħa.
English: Atrioventricular block first degree Ventricular extrasystoles* Supraventricular extrasystoles
Maltese: Ekstrasistols ventrikulari* Ekstrasistols supraventrikulari
English: Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (type A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate
Maltese: Il-qalba tal-pillola Hypromellose phthalate Povidone all-rac-α-Tocopherol Cellulose, microcrystalline Sodium starch glycolate (tip A) Carmellose calcium Silica, colloidal hydrated Magnesium stearate Lactose monohydrate
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%).
Maltese: Ottimizzat fl-Isfond (OBR, Optimised Background Regimen) (i.e. inċidenza > 10 %) huma dardir (32.9 %), rimettar (29.9 %), uġigħ ta' ras (27.6 %), nuqqas ta' rqad (27.3 %), stordament (22.4 %,) tinnite (16.5 %), ipokalemija (16.2 %), gastrite (15.0 %), nuqqas t'aptit (13.1 %), u astenija (11.3%).
English: Date of first authorisation: 28 April 2014 Date of latest renewal: 2 April 2019
Maltese: Data tal-aħħar tiġdid: 2 ta' April 2019
English: Leukopenia Thrombocytopaenia
Maltese: Lewkopenija Tromboċitopenija
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).
Maltese: - Is-sustanzi l-oħra huma 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).
English: Hereford, HR3 5PG United Kingdom
Maltese: Hereford, HR3 5PG Ir-Renju Unit
English: Frequency common
Maltese: Frekwenza komuni
English: Delamanid has a large apparent volume of distribution (Vz/F of 2,100 L).
Maltese: Delamanid għandu volum apparenti kbir ta' distribuzzjoni (Vz/F ta' 2,100 L).
English: Dehydration Hypocalcaemia Hypercholesterolaemia
Maltese: Deidrazzjoni Ipokalċemija Iperkolesterolemija
English: The identified metabolites of delamanid do not show anti-mycobacterial activity.
Maltese: Il-metaboliti identifikati ta' delamanid ma jurux attività antimikobatterika.
English: Delamanid is contraindicated in patients with albumin <2.8 g/dL (see section 4.3).
Maltese: Delamanid huwa kontraindikat f'pazjenti b'livell t'albumina <2.8 g/dL (ara sezzjoni 4.3).
English: Table: Adverse drug reactions to delamanid System Organ
Maltese: Tabella: Reazzjonijiet avversa tal-mediċina għal delamanid Sistema tal-Klassifika tal-Organi
English: Pharmacotherapeutic group: Antimycobacterials, antibiotics, ATC code: J04AK06.
Maltese: Kategorija farmakoterapewtika: Antimikobatterjali, antibijotiċi, Kodiċi ATC:
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).
Maltese: Il-ħin medjan sa SCC kien ta' 51 jum fil-grupp ta' delamanid + OBR meta mqabbel ma' 57 jum fil-grupp ta' PLC + OBR (p = 0.0562 permezz tal-modifikazzjoni stratifikata modifikata Peto-Peto tat-test tas-somma klassifikata Wilcoxon ta' Gehan).
English: QTc prolongation is very closely correlated with the major delamanid metabolite DM-6705.
Maltese: It-titwil ta' QT huwa korelatat mill-qrib ħafna mal-metabolit ewlieni ta' delamanid DM-6705.
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.
Maltese: Il-mod t'azzjoni farmakoloġika ta' delamanid jinvolvi l-impediment tas-sintesi tal-komponenti tar-riti ċellulari mikobatteriċi, methoxy-mycolic u ketomycolic acid.
English: carbamazepine).
Maltese: mizolastine).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose,
English: Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%.
Maltese: Delamanid jingħaqad b'mod qawwi mal-proteini fil-plażma kollha b'rabta ma' proteini totali ta' ≥99.5%.
English: Within each System Organ Class, adverse reactions are listed under frequency categories of very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Fi ħdan kull Sistema tal-Klassifika tal-Organi, reazzjonijiet avversi huma elenkati skont kategoriji ta' frekwenza ta' komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa <1/10), mhux komuni ( ≥ 1/1, 000 sa <1/100), rari ( ≥ 1/10, 000 sa <1/1, 000 ), rari ħafna (<1/10, 000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Transaminases increased* Activated partial thromboplastin time prolonged*
Maltese: Investigazzjonijiet Dipressjoni fis-segment ST tal-elettrokardjogramma Żieda fit-transaminases* Titwil fl-activated partial thromboplastin time*
English: Delamanid is primarily metabolised in plasma by albumin and to a lesser extent by CYP3A4.
Maltese: Delamanid huwa prinċipalment metabolizzat bl-albumina fil-plażma u fi grad inqas minn CYP3A4.
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.
Maltese: OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 u BSEP, f'konċentrazzjonijiet ta' madwar 5 sa 20
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.
Maltese: (200 mg kuljum) u ma rifampicin/isoniazid/pyrazinamide (300/720/1800 mg kuljum) jew ethambutol (1100 mg kuljum) għal 15-il jum.
English: Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks.
Maltese: Konċentrazzjonijiet tal-metaboliti identifikati jiżdiedu progressivament għal stadju fiss wara 6 sa 10 ġimgħat.
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”).
Maltese: It-tnejn urew ħin medjan iqsar ta' 13-il jum għal SCC fil-grupp ta' delamanid + OBR (p = 0.0281 għal LOCF u p = 0.0052 għal “bookending”).
English: Effects of other medicinal products on Deltyba
Maltese: Effetti ta' prodotti mediċinali oħra fuq Deltyba
English: - One film-coated tablet contains 50 mg of the active substance delamanid.
Maltese: - Pillola waħda miksija b'rita fiha 50 mg tas-sustanza attiva delamanid.
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.
Maltese: L-inċidenza ta' intervall QTcF > 500 ms kienet tvarja minn 0.6 % (1/161) -2.1 % (7/341) f'pazjenti li rċevew doża totali ta' 200 mg delamanid kuljum kontra 0 % (0/160) - 1.2 % (2/170) ta'
English: Mild renal impairment (50 mL/min < CrCLN < 80 mL/min) does not appear to affect delamanid exposure.
Maltese: (50 mL/min < CrCLN < 80 mL/min) ma jidhirx li jaffettwa l-esponiment ta' delamanid.
English: Susceptibility testing breakpoints
Maltese: Punti ta' referenza għal testijiet ta' suxxetibilità
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).
Maltese: Il-lista ta' reazzjonijiet avversi għall-mediċina u l-frekwenzi huma bbażati fuq riżultati minn 2 provi kliniċi double-blind bi plaċebo bħala kontroll (delamanid flimkien ma' OBR, n = 662 versus placebo ma' OBR n = 330).
English: Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita fiha 100 mg lactose (bħala monohydrate).
English: Exposure of concomitant anti-TB drugs (rifampicin [R]/ isoniazid [H]/ pyrazinamide [Z]) was not affected.
Maltese: [R]/isoniazid [H]/pyrazinamide [Z]) ma ġiex affettwat.
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.
Maltese: L-esponiment ta' delamanid ma nbidlitx (differenza ta'inqas minn 25%) mal-mediċini ta' kontra l-HIV, tenofovir disoproxil u efavirenz iżda żdied bi ftit bil-kombinazzjoni tal-mediċina kontra l-HIV li kien fiha lopinavir/ritonavir.
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).
Maltese: Il-proporzjon ta' pazjenti li kisbu SCC (konverżjoni tal-kultura ta' sputum) wara l-perijodu ta' trattament ta' 6 xhur kien ta' 87.6 % (198/226) fil-grupp ta' trattament ta' delamanid + OBR ipparagunat ma' 86.1 %
English: These include (but are not limited to): - Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Maltese: Dawn jinkludu (imma mhumiex ristretti għal): - Antiarritmiċi (eż. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine,
English: Eosinophilic pustular folliculitis* Pruritus generalised* Rash erythematous
Maltese: Alopeċja* Follikulitè pustulari eosinofilika* Ħakk ġeneralizzat* Raxx eritematuż
English: Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.
Maltese: Deltyba jiġi f'pakketti ta' 48 pillola miksija b'rita f'folji tal-aluminju/aluminju.
English: Resistance to delamanid
Maltese: Reżistenza għal delamanid
English: Deltyba 50 mg film-coated tablets delamanid
Maltese: Deltyba 50 mg pilloli miksija b'rita delamanid
English: - if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
Maltese: - Ċertu antistamini li mhumiex kalmanti (eż terfenadine, astemizole, mizolastine).
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.
Maltese: Madankollu, tagħrif addizzjonali kliniku wera li f'pazjenti li rċevew 200 mg darbtejn kuljum, i.e total ta' 400 mg delamanid kuljum, il-profil tas-sigurtà globali huwa komparabbli ma' dak ta' pazjenti li qed jirċievu d-doża rakkomandata ta' 100 mg darbtejn kuljum.
English: Plasma albumin and CYP3A4 regulate the formation and metabolism of DM-6705 respectively (see Special Considerations below).
Maltese: L-albumina fil-plażma u CYP3A4 jirregolaw il-formazzjoni u l-metaboliżmu ta' DM-6705 eispettivament (ara Konsiderazzjonijiet Speċjali hawn isfel).
English: Elderly patients (> 65 years of age)
Maltese: Pazjenti anzjani (≥ 65 sena)
English: In the dog, foamy macrophages were observed in lymphoid tissue of various organs during repeat-dose toxicity studies.
Maltese: Fil-klieb, ġew osservati makrofaġi bir-ragħwa fit-tessut limfojdi ta' diversi organi varji waqt studji ta' tossiċità b'dożi ripetuti.
English: Frequency uncommon
Maltese: Frekwenza komuni ħafna
English: • Allergic conjunctivitis
Maltese: • Konġunktivite allerġika
English: • Rash
Maltese: • Newrosi
English: Liver disorders is categorised as an important potential risk.
Maltese: Id-disturbi tal-fwied huma katagorizzati bħala riskju potenzjali importanti.
English: Oral bioavailability of delamanid improves when administered with a standard meal, by about 2.7 fold compared to fasting conditions.
Maltese: Il-bijodisponibilità orali ta' delamanid titjib meta jingħata ma ikla standard b'madwar 2.7 darbiet meta mqabbla ma' kondizzjonijiet ta' sawm.
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.
Maltese: Delamanid mogħti f'kombinazzjoni mal mediċini ta' kontra l-HIV, tenofovir disoproxil, lopinavir/ritonavir u efavirenz, ma affettwax l-espożizzjoni għal dawn il-prodotti mediċinali.
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.
Maltese: F'pazjenti li rċevew doża totali ta' 200 mg delamanid kuljum fil-provi ta' fażi 2 u 3, iż-żieda kkorreġuta medja ta' plaċebo f'QTcF mil-linja bażi kienet fil-medda minn 4.7 - 7.6 ms f'xahar u 5.3 ms - 12.1 ms f'xahrejn rispettivament.
English: The identified metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM6705.
Maltese: Il-metaboliti identifikati ma jurux attività antimikobatterika imma xi wħud jikkontribwixxu għat-titwil ta' QTc, prinċipalment minħabba DM-6705.
English: ECG QT interval prolongation
Maltese: Titwil tal-intervall tal-ECG QT
English: Effects of Deltyba on other medicinal products
Maltese: Effetti ta' Deltyba fuq prodotti mediċinali oħra
English: - Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
Maltese: - Newrolettiċi (eż. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol,
English: All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis.
Maltese: Kull kultura nieqsa saż-żmien ta' SCC kienet preżunta li hija ta' kultura pożittiva fl-analiżi primarja.
English: • Panic attacks
Maltese: • Attakki ta' paniku
English: Chest discomfort* Oedema peripheral*
Maltese: Dwejjaq fis-sider* Edema periferali*
English: Resistance to delamanid has been documented to occur during treatment (see section 4.4).
Maltese: Reżistenza għal delamanid ġiet dokumentata li sseħħ waqt it-trattament (ara sezzjoni 4.4).
English: Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.
Maltese: Deltyba fih is-sustanza attiva delamanid, antibijotiku għall-kura ta' tuberkolosi fil-pulmun ikkawżat minn batterja li ma jiġux maqtula minn antibijotiċi komuni użati biex jikkuraw it-tuberkolosi.
English: Trial 204 and 2 of 511 patients in Trial 213 (4 of 827 patients [0.48%]).
Maltese: MIC ≥ 0.2 µg/mL) ġiet osservata fil-linja bażi fi 2 minn 316-il pazjent fi Prova 204 u fi2 minn 511-il pazjent fi Prova 213 (4 minn 827 pazjent [0.48 %]).
English: Mental disorder
Maltese: Disturb psikotiku
English: • Difficulties with falling or staying asleep
Maltese: • Disturb t'aġġustament u burdata depressa
English: Urticaria
Maltese: Dijarea
English: * The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the placebo plus OBR group.
Maltese: * Il-frekwenza ta' dawn il-każijiet kien inqas baxx fil-grupp ta' delamanid ikkombinat ma' OBR meta mqabbel mal-grupp tal-plaċebo ma' OBR.
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).
Maltese: Deltyba huwa indikat bħala parti minn programm ta' kura kkombinata xierqa għal tuberkulosi pulmonari reżistenti għal diversi mediċini (MDR-TB) f'pazjenti adulti meta programm ta' kura effettiv ma jistax jiġi kompost mod ieħor għal raġunijiet ta' reżistenza jew tolerabilità (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Hepatic function abnormal
Maltese: Funzjoni tal-fwied abnormali
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch.
Maltese: L-MAH (Marketing Authorization Holder - Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq) għandu jiftiehem dwar il-materjal edukattiv mal-Istati Membri, qabel it-tnedija.
English: • Balance disorder
Maltese: • Disturbi fil-bilanċ
English: Dysphoria
Maltese: Disfaġja
English: Delusional disorder, persecutory type
Maltese: Disturb ta' paniku ta' tip persekutorju,
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).
Maltese: BID + OBR u 37/125 (29.6 %) tal-pazjenti magħżula b'mod każwali biex jirċievu plaċebo (PLC) + OBR kisbu konverżjoni tal-kultura ta' sputum (SCC, sputum culture conversion) fuq xahrejn (jiġifieri żvilupp ta' Mycobacterium tuberculosis għall-ebda żvilupp matul l-ewwel xahrejn u miżmum għal xahar ieħor) (p = 0.0083).
English: Co-administration with strong inhibitors of CYP3A4
Maltese: L-għoti flimkien ma' impedituri qawwija ta' CYP3A4
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.
Maltese: Għal pazjenti li jirċievu 100 mg delamanid + OBR darbtejn kuljum, il-frekwenza kienet ta' 8.1 % (kategorija ta' frekwenza, komuni) meta mqabbla ma' frekwenza ta' 6.3 % f'pazjenti li jirċievu plaċebo +OBR darbtejn kuljum.
English: Hyperhidrosis
Maltese: Ipertrigliċeridemija
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u tan-nutrizzjoni
English: Medicinal products with the potential to prolong QTc
Maltese: Prodotti mediċinali bil-potenzjal li jtul il-QTc
English: Psychotic disorder Agitation
Maltese: Disturb psikotiku Agitazzjoni Ansjetà u disturbi ta' ansjetà
English: How to store Deltyba
Maltese: Tiħux Deltyba:
English: Each film-coated tablet contains: 50 mg delamanid
Maltese: Kull pillola miksija b'rita fiha: 50 mg delamanid
English: In-vitro studies showed that delamanid did not inhibit CYP450 isozymes.
Maltese: Studji in-vitro wrew li delamanid ma jimpedixxix l-isoenzimi ta' CYP450.