FrancophonIA/ELRC3.0 huggingface dataset:
English: B cell function: All 12 subjects treated in the pivotal study were receiving IVIG therapy at the time of screening, and 7 subjects (58%) had discontinued IVIG use during 0-3 years follow-up after gene therapy.
Maltese: Funzjoni taċ-ċellula B: It-12-il individwu kkurati fl-istudju pivotali kienu qed jirċievu terapija ta' immunoglobulina minn ġol-vina (IVIG) fiż-żmien tal-iskrinjar, u 7 individwi (58%) kienu waqqfu l-użu talIVIG waqt segwitu ta' 0-3 snin wara t-terapija tal-ġeni.
English: History of previous gene therapy.
Maltese: Storja preċedenti ta' terapija tal-ġeni.
English: CD34+ cells derived from healthy human umbilical cord blood, transduced with the vector used for the production of Strimvelis, were administered intravenously to busulfan-conditioned mice.
Maltese: Iċ-ċelluli CD34+ meħuda mid-demm tal-kurdun umbilikali tal-bniedem, transdott bil-vettur użat għall-produzzjoni ta' Strimvelis, ingħataw minn ġol-vina lil ġrieden ikkondizzjonati b'busulfan.
English: Results at 3 years for the ITT population in the pivotal study*
Maltese: 3 ijiem u jumejn qabel kura
English: Year 3/ 3 Years Post-Treatmentb
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Positive test for human immunodeficiency virus (HIV) or presence of any other transmissible infectious agent listed in the current EU Cell and Tissue Directive prior to bone marrow harvest.
Maltese: Test pożittiv għal virus tal-immunodefiċjenza umana (HIV) jew preżenza ta' kwalunkwe aġent infettjuż trasmissibbli ieħor elenkat fid-Direttiva taċ-Ċelluli u t-Tessuti tal-UE attwali qabel il-ġbir tal-mudullun.
English: Interventionfree survival in this pivotal population (defined as survival without the requirement for long-term (≥3 month) re-introduction of PEG-ADA, or stem cell transplant) was 92% (11/12 subjects) (82% (14/17 subjects) for integrated population).
Maltese: Is-sopravivenza mingħajr intervent f'din il-popolazzjoni pivotali (definita bħala sopravivenza mingħajr ilħtieġa ta' introduzzjoni mill-ġdid fit-tul (≥3 xhur) ta' PEG-ADA, jew trapjant tal-mudullun) kienet ta' 92% (82% għall-popolazzjoni integrata).
English: • red or purple dots on the skin, bleeding under the skin (immune thrombocytopenic purpura)
Maltese: • tikek ħomor jew vjola fuq il-ġilda, fsada taħt il-ġilda (purpura tromboċitopenika immuni)
English: The MAH will follow up on the risk of immunogenicity, insertional mutagenesis and oncogenesis as well as hepatic toxicity.
Maltese: L-MAH ser isegwi r-riskju ta' immunoġeniċità, mutaġenesi inserzjonali u onkoġenesi kif ukoll effett tossiku fuq ilfwied.
English: by a drip into a vein.
Maltese: permezz ta' dripp ġol-vina.
English: No cases of leukaemia or myelodysplasia have been reported following treatment with Strimvelis.
Maltese: Dan minħabba li Strimvelis huwa prodott ta' terapija tal-ġeni.
English: Hypertensiona
Maltese: Ipotajrojdiżmu
English: Premedication
Maltese: FARMAĊEWTIKU
English: There were no adverse effects on survival, haematological parameters or histopathology of major organs, apart from body weight loss and atrophy in the testes and ovaries consistent with administration of busulfan.
Maltese: Ma kienx hemm effetti avversi fuq is-sopravivenza, parametri ematoloġiċi jew istopatoloġija ta' organi ewlenin, apparti mittelf tal-piż tal-ġisem u atrofija fuq it-testikoli u l-ovarji konsistenti mal-għoti ta' busulfan.
English: Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)matched related stem cell donor is available (see section 4.2 and section 4.4).
Maltese: Strimvelis huwa indikat għall-kura ta' pazjenti b'immunodefiċjenza kkombinata severa minħabba defiċjenza ta' adenosine deaminase (ADA-SCID), li għalihom donatur xieraq taċ-ċelluli staminali relatati mqabbla talantiġen tal-lewkoċiti tal-bniedem (HLA) mhuwiex disponibbli.
English: A 4-month biodistribution study was performed in mice.
Maltese: Twettaq studju tal-bijodistribuzzjoni ta' 4 xhur fil-ġrieden.
English: Non-interventional PASS: In order to investigate the long term safety and efficacy of Strimvelis gene therapy, the MAH should conduct and submit the results of a long term prospective, non-interventional follow up study using data from a registry of patients with adenosine deaminase severe combined immunodeficiency (ADA-SCID) treated with Strimvelis.
Maltese: Sabiex jinvestiga s-sigurtà u l-effikaċja fit-tul tat-terapija tal-ġeni Strimvelis, il-MAH għandu jwettaq u jippreżenta r-riżultati ta' studju ta' segwitu mhux ta' intervent, prospettiv fittul bl-użu ta' dejta minn reġistru ta' pazjenti b'immunodefiċjenza kkombinata severa ta' adenosine deaminase (ADA-SCID) kkurati bi Strimvelis.
English: The educational materials should address the following safety concerns/key elements: Autoimmunity, Unsuccessful response to gene therapy, and Malignancy due to insertional oncogenesis (e.g. leukaemia, myelodysplasia).
Maltese: Il-materjali edukattivi għandhom jindirizzaw it-tħassib/l-elementi ewlenin dwar is-sigurtà li ġej/jin: Awtoimmunità, Rispons li ma jkunx irnexxa għal terapija bil-ġeni, u Tumuri malinni minħabba onkoġenesi inserzjonali (eż. lewkimja, majelodisplażja).
English: The quantitative information regarding CD34+ cells/kg and total cells in the product is presented in the labelling for each batch.
Maltese: L-informazzjoni kwantitattiva rigward ċelluli CD34+/kg u ċ-ċelluli totali fil-prodott hija ppreżentata fittikkettar għal kull lott.
English: Non-immunological manifestations of ADA-SCID may not respond to Strimvelis.
Maltese: Manifestazzjonijiet mhux immunoloġiċi ta' ADA-SCID jistgħu ma jirrispondux għal Strimvelis.
English: Time period (Years)
Maltese: NUMRU(I)
English: Patients who have previously tested positive for hepatitis C can be treated with Strimvelis, provided they demonstrate absence of ongoing infection using a nucleic acid test with a limit of quantification of ≤15 international units/ml.
Maltese: Il-pazjenti li preċedentement ikunu ġew ittestjati pożittivi għall-epatite Ċ jistgħu jiġu kkurati bi Strimvelis, jekk juru nuqqas ta' infezzjoni li tkun għadha għaddejja bl-użu ta' test ta' aċidu nuklejku b'limitu ta' kwantifikazzjoni ta' ≤15-il unità internazzjonali/ml.
English: Table 2 Rate of severe infections per person year of exposure (pivotal population)* Pre treatment
Maltese: Tabella 2 Rata ta' Infezzjonijiet Severi Għal Kull Sena ta' Persuna ta' Esponiment b'Sena (Popolazzjoni Pivitali)
English: The final clinical study report should be submitted after the 50th patient has 15 year follow-up visit; Q4 2037.
Maltese: Irrapport finali tal-istudju kliniku għandu jkun ippreżentat wara li lpazjent numru 50 ikollu żżjara ta' segwitu ta' 15il sena; Q4
English: A medicine called busulfan is given four times a day for two days (total of 8 doses)
Maltese: Mediċina bl-isem ta' busulfan tingħata erba' darbiet kuljum għal jumejn (total ta' 8 dożi)
English: How to store Strimvelis
Maltese: Tirojdite awtoimmuni
English: The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Maltese: Is-sigurtà u l-effikaċja ta' Strimvelis fit-tfal ta'età ta' anqas minn sitt xhur jew ta' 'il fuq minn 6 snin u xahar ma ġewx iddeterminati s'issa (ara sezzjoni 4.4).
English: Patients who previously received PEG-ADA had this treatment withdrawn 10 to 22 days prior to Strimvelis therapy.
Maltese: Il-pazjenti li rċevew PEG-ADA minn qabel twaqqfitilhom din il-kura 10 sa 22 jum qabel it-terapija bi Strimvelis.
English: Local biosafety guidelines applicable should be followed.
Maltese: Għandhom jiġu segwiti linji gwida lokali dwar il-bijosigurtà applikabbli.
English: Baseline/ Pre-Treatmenta
Maltese: IL-PRODOTT MEDIĊINALI
English: There are no data on the effects of Strimvelis on human fertility.
Maltese: M'hemmx data fuq l-effetti ta' Strimvelis fuq il-fertilità tal-bniedem.
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Maltese: Għandhom jiġu segwiti linji gwida lokali dwar il-bijosigurtà applikabbli għal prodotti bħal dawn (ara sezzjoni 6.6).
English: * Including data from one patient collected post intervention with PEG-ADA (>3 months treatment) or hematopoietic stem cell transplantation a Based on the entire pre-treatment period for severe infections (retrospectively collected), and the data collected at the baseline visit for T-lymphocytes.
Maltese: Tużax din il-mediċina wara d-data u ż-żmien ta' meta tiskadi (JIS) li tidher fuq it-tikketta tar-reċipjent u ttikketta tal-borża tal-infużjoni.
English: (pomalidomide)
Maltese: (pomalidomid)
English: EMA/240195/2019 EMEA/H/C/002682
Maltese: EMA/240195/2019 EMA/H/C/002682
English: Imnovid is available as capsules (1, 2, 3 and 4 mg).
Maltese: Imnovid jiġi bħala kapsuli (1, 2, 3 u 4 mg).
English: Further information on the orphan designation can be found on ema.europa.eu/medicines/human/orphan-designations/EU309672.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/EU309672
English: This overview was last updated in 04-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'04-2019.
English: Further information on Imnovid can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
Maltese: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
English: Other information about Imnovid
Maltese: Informazzjoni oħra dwar Imnovid
English: The active substance in Imnovid, pomalidomide, is an immunomodulating agent.
Maltese: Is-sustanza attiva f'Imnovid, il-pomalidomid, hija aġent immunomodulanti.
English: Imnovid received a marketing authorisation valid throughout the EU on 5 August 2013.
Maltese: Imnovid irċieva awtorizzazzjoni għat-tqegħid fis-suq valida mal-UE kollha fil-5 ta' Awwissu 2013.
English: Previously known as Pomalidomide Celgene.
Maltese: Qabel magħruf bħala Pomalidomide Celgene.
English: Imnovid contains the active substance pomalidomide.
Maltese: Imnovid fih is-sustanza attiva pomalidomid.
English: The company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Maltese: Il-kumpanija li tipproduċi Imnovid se tistabbilixxi programm għall-prevenzjoni tat-tqala f'kull Stat Membru.
English: The medicine packs containing Imnovid capsules will carry a warning on the risk of severe birth defects.
Maltese: Il-pakketti tal-mediċina li jkun fihom il-kapsuli Imnovid se jkollhom twissija dwar ir-riskju ta' difetti severi fit-twelid.
English: What are the risks associated with Imnovid?
Maltese: X'inhuma r-riskji assoċjati ma' Imnovid?
English: Multiple myeloma is rare, and Imnovid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Maltese: Il-mijeloma multipla hija rari u Imnovid ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ottubru 2009.
English: It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
Maltese: Jintuża flimkien ma' borteżomib (mediċina oħra kontra l-kanċer) u dexamethasone (mediċina antiinfjammatorja) f'adulti li rċevew tal-inqas kura waħda inkluż lenalidomid (mediċina oħra kontra l-kanċer).
English: Serious side effects, which affect up to 1 in 10 patients, include blood disorders (such as neutropenia, anaemia and thrombocytopenia), lower respiratory tract infection (such as bronchitis or pneumonia), pulmonary embolism (clot in a blood vessel in the lungs), flu, and acute kidney injury.
Maltese: Effetti sekondarji serji, li jaffettwaw sa pazjent 1 minn kull 10, jinkludu disturbi tad-demm (bħal newtropenija, anemija u tromboċitopenija), infezzjoni tal-apparat respiratorju t'isfel (bħal bronkite jew pulmonite), emboliżmu pulmonari (fsada f'vażu taddemm fil-pulmun), influwenza, u korriment akut tal-kliewi.
English: Imnovid is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow).
Maltese: Imnovid huwa mediċina kontra l-kanċer użata biex tikkura adulti b'mijeloma multipla (kanċer talmudullun).
English: The most common side effects with Imnovid (which affect more than 1 in 10 patients), some of which can be serious, include anaemia (low red blood cell counts), neutropenia (low white blood cell count), tiredness, thrombocytopenia (low platelet counts), fever, peripheral oedema (swelling of the limbs due to fluid retention), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet) and infections including pneumonia (infection of the lungs).
Maltese: L-effetti sekondarji l-aktar komuni b'Imnovid (li jaffettwaw aktar minn pazjent 1 minn kull 10), li wħud minnhom jistgħu jkunu serji, jinkludu l-anemija (għadd baxx ta' ċelloli tad-demm ħomor), newtropenija (għadd baxx ta' ċelloli tad-demm bojod), għeja, tromboċitopenija (għadd baxx ta' pjastrini), deni, edema periferika (nefħa tar-riġlejn jew tad-dirgħajn minħabba żamma ta' fluwidu), newropatija periferika (ħsara fin-nervituri li tikkawża tingiż, uġigħ u tnemnim fl-idejn u s-saqajn) u infezzjonijiet inklużi pulmonite (infezzjoni tal-pulmun).
English: The company will also provide final results from a study with Imnovid in combination with bortezomib and dexamethasone in patients with multiple myeloma who had received at least one treatment including lenalidomide, to confirm the medicine's effect on overall survival.
Maltese: Il-kumpanija se tipprovdi wkoll riżultati finali minn studju b'Imnovid f'kombinazzjoni ma' borteżomib u dexamethasone f'pazjenti b'majeloma multipla li rċevew mill-inqas kura waħda inkluż lenalidomid, biex tikkonferma l-effett tal-mediċina fuq is-sopravivenza ġenerali.
English: Pomalidomide works in a number of ways in multiple myeloma, similarly to other immunomodulating medicines such as lenalidomide and thalidomide: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Maltese: Il-pomalidomid taħdem f'numru ta' diversi modi fil-mijeloma multipla, b'mod simili għal mediċini oħra immunomodulanti bħal-lenalidomid u ttalidomid: timblokka l-iżvilupp ta' ċelloli ta' tumuri, tipprevjeni li l-vażi jikbru f'tumuri u tistimula wkoll xi ċelloli speċjalizzati tas-sistema immunitarja biex jattakkaw iċ-ċelloli tat-tumuri.
English: How is Imnovid used?
Maltese: Kif jaħdem Imnovid ?
English: Imnovid has been studied in one main study involving 455 adults with multiple myeloma whose disease did not get better or came back after previous treatments.
Maltese: Imnovid ġie investigat fi studju ewlieni wieħed li kien jinvolvi 455 adult bil-mijeloma multipla li l-marda tagħhom ma ġietx għall-aħjar jew li reġgħet tfaċċat wara kuri preċedenti.
English: A further study included 559 patients with multiple myeloma who had received at least one treatment including lenalidomide, and whose disease got worse during or after their last treatment.
Maltese: Studju ieħor kien jinkludi 559 pazjent b'majeloma multipla li rċevew mill-inqas kura waħda inkluż lenalidomid, u li l-marda tagħhom marret għall-agħar matul jew wara l-aħħar kura tagħhom.
English: For the full list of side effects and restrictions with Imnovid, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Imnovid, ara l-fuljett ta' tagħrif.
English: As for all medicines, data on the use of Imnovid are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Imnovid hija ssorveljata kontinwament.
English: Patients treated with Imnovid, bortezomib and low-dose dexamethasone lived on average 11.2 months before their disease got worse, compared with 7.1 months for patients treated with bortezomib and low dose dexamethasone.
Maltese: Ilpazjenti li ngħataw kura b'Imnovid, borteżomib u doża baxxa ta' dexamethasone għexu medja ta' 11.2 xhur qabel ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 7.1 xhur għal pazjenti kkurati b'borteżomib u doża baxxa ta' dexamethasone.
English: It is taken in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
Maltese: Dan jittieħed fl-ewwel ġimagħtejn ta' ċikli ta' kura ta' 3 ġimgħat, meta jingħata f'kombinazzjoni ma' borteżomib u dexamethasone, u fl-ewwel 3 ġimgħat ta' ċikli ta' kura ta' 4 ġimgħat meta jingħata f'kombinazzjoni ma' dexamethasone biss.
English: Capsules length: 24.2 mm.
Maltese: Daqs tal-kapsula: 24.2 mm.
English: C] isavuconazonium and [pyridinylmethyl
Maltese: C] isavuconazole u [pyridinylmethyl
English: Laboratory effects
Maltese: Effetti tal-laboratorju
English: Mycophenolate mofetil (MMF) (UGT substrate)
Maltese: Mycophenolate mofetil (MMF) (sottostrat ta' UGT)
English: Caffeine:
Maltese: Kaffeina:
English: NNRTI, non-nucleoside reverse-transcriptase inhibitor; P-gp, P-glycoprotein.
Maltese: NNRTI, non-nucleoside reverse-transcriptase inhibitor (impeditur ta' reverse transcriptase mhux nukleoside); P-gp, P-glycoprotein.
English: Mycophenolic acid (MPA, active metabolite) :
Maltese: Mycophenolic acid (MPA, metabolit attiv):
English: CV % tmax (h)
Maltese: CV % tmax (h) Medjan
English: Pfizer ΕΛΛΑΣ Α.Ε.
Maltese: Pfizer ΕΛΛΑΣ A.E.
English: Dextrorphan (active metabolite): AUCinf: ↑ 4%
Maltese: Dextrorphan (metabolit attiv): AUCinf: ↑ 4%
English: Excipients: mannitol (E421) and sulfuric acid
Maltese: Eċċipjenti: mannitol (E421) u sulfuric acid
English: Table 1 Interactions
Maltese: Tabella 1 Interazzjonijiet
English: Uridine diphosphate-glucuronosyltransferases (UGT) substrates
Maltese: Sottostrati ta' uridine diphosphate glucuronosyltransferases (UGT)
English: Natural products Caffeine (CYP1A2 substrate)
Maltese: Prodotti naturali Kaffeina (Sottostrat ta' CYP1A2)
English: The adverse reactions which most often led to permanent discontinuation of CRESEMBA treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnoea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%).
Maltese: Ir-reazzjonijiet avversi li ta' spiss wasslu għal twaqqif permanenti ta'CRESEMBA kienu stat konfużjonali (0.7%), falliment akut tal-kliewi (0.7%), żieda ta' bilirubina fid-demm (0.5%), konvulżjoni (0.5%), dispnea (0.5%), epilessija (0.5%), falliment respiratorju (0.5%) u remettar (0.5%).
English: Following single doses of [cyano
Maltese: Wara dożi uniċi ta' [cyano
English: (OCT2 inhibition)
Maltese: (impediment ta' OCT2)
English: The adjusted treatment difference (voriconazole−isavuconazole) was 4.0% (95% confidence interval: −7.9; 15.9).
Maltese: Id-differenza fit-trattament aġġustat (voraconazole-isavuconazole) kien ta' 4.0% (intervall ta' fiduċja ta' 95%: -7.9: 15,9).
English: Vinca alkaloids (vincristine, vinblastine) (P-gp substrates)
Maltese: Kontra l-kanċer Alkalojdi vinca (vincristine, vinblastine) (Sottostrati ta' P-gp)
English: Mean plasma concentrations (Cmax) were 2% lower in the Child-Pugh Class A group and 30% lower in the Child-Pugh Class B group.
Maltese: Konċentrazzjonijiet medji fil-plażma (Cmax) kienu 2% inqas filgrupp ta' Child-Pugh Klassi A u 30% inqas fil-grupp ta' Child-Pugh Klassi B.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Maltese: Peress li ser tingħata din il-mediċina taħt superviżjoni medika attenta, mhux probabbli li doża ma tingħatax.
English: See sections 4.2 and 4.4.
Maltese: Ara sezzjonijiet 4.2 u 4.4.
English: Metformin (OCT1, OCT2 and MATE1 substrate)
Maltese: Metformin (sottostrat ta' OCT1, OCT2 u MATE1)
English: Methotrexate (BCRP, OAT1, OAT3
Maltese: Methotrexate (sottostrat ta' BCRP, OAT1, OAT3)
English: Repaglinide (CYP2C8 and OATP1B1 substrate)
Maltese: Repaglinide (sottostrat ta' CYP2C8 u OATP1B1)
English: Immunosuppresants Ciclosporin, sirolimus, tacrolimus (CYP3A4/5 substrates)
Maltese: Immunosoppressanti Ciclosporin, sirolimus, tacrolimus (sottostrati ta' CYP3A4/5)
English: Treatment of mucormycosis
Maltese: Trattament ta' mukormikosi
English: Medicinal products renally excreted via transport proteins
Maltese: Prodotti mediċinali eliminati mill-kliewi permezz ta proteini trasportaturi
English: S-methadone (inactive opiate isomer)
Maltese: S-methadone (isomeru ta' opiate mhux attiv)
English: Table 4Pharmacokinetic comparison for oral and intravenous dose (Mean) ISA 400 mg oral
Maltese: Tabella 4 Tqabbil farmakokinetiku għal dożi orali u ġol-vina (Medja) ISA 400 mg orali
English: See sections 4.2, 4.8 and 5.2.
Maltese: Ara sezzjonijiet 4.2, 4.8 u 5
English: Medicinal products metabolised by CYP2B6
Maltese: Prodotti mediċinali metabolizzati b'CYP2B6
English: (UGT inhibition)
Maltese: (impediment ta' UGT)
English: Median treatment duration was 45 days.
Maltese: Iż-żmien medjan ta' trattament kien ta' 45 jum.
English: Isavuconazole is a mild inhibitor of the organic cation transporter 2 (OCT2).
Maltese: Isavuconazole huwa impeditur ħafif tat-trasportatur 2 ta' katjoni organiċi (organic cation transporter 2, OCT2).
English: 14 hard capsules
Maltese: 14-il kapsula iebsa
English: Capsule shell hypromellose water red iron oxide (E172) (capsule body only) titanium dioxide (E171) gellan gum potassium acetate disodium edetate sodium laurilsulfate
Maltese: Il-qoxra tal-kapsula hypromellose ilma red iron oxide (E172) (korp tal-kapsula biss) titanium dioxide (E171) gellan gum potassium acetate disodium edetate sodium laurilsulfate
English: Methadone (CYP3A4/5, 2B6 and 2C9 substrate)
Maltese: Methadone (Sottostrat ta' CYP3A4/5, 2B6 u 2C9)
English: The DRC-assessed overall success rate at EOT was 11/35 (31.4%), with 5 patients considered completely cured and 6 patients partially cured.
Maltese: Ir-rata ta' suċċess globali assessjat mid-DRC f'EOT ta' 11/35 (31.4%) b'5 pazjenti kkunsidrati kkurati totalment u 6 pazjenti kkurati parzjalment.
English: Printing ink shellac propylene glycol potassium hydroxide black iron oxide (E172)
Maltese: Linka tal-istampar shellac propylene glycol potassium hydroxide black iron oxide (E172)
English: The adjusted treatment difference (isavuconazole−voriconazole) was −2.7% (95 % confidence interval: −12.9; 7.5).
Maltese: Id-differenza fit-trattament aġġustat (isacuconazolevoraconazole) kien ta' -2.7 (intervall ta' fiduċja ta' 95%: -12.9: 7,5).
English: Isavuconazole is an inducer of CYP2B6.
Maltese: Isavuconazole huwa induttur ta' CYP2B6.
English: Antitussives Dextromethorphan (CYP2D6 substrate)
Maltese: Dextromethorphan (sottostrat ta' CYP2D6)
English: Cmax (ng/mL) Mean
Maltese: Cmax (ng/mL) Medja
English: - Capsule shell: hypromellose, water, red iron oxide (E172) (capsule body only), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate.
Maltese: - Il-qoxra tal-kapsula: hypromellose, ilma, red iron oxide (E172) (korp tal-kapsula biss), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate.
English: The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
Maltese: L-aktar reazzjonijiet komuni avversi marbuta mat-trattament kienu testijiet kimiċi elevati tal-fwied (7.9%), dardir(7.4%), remettar (5.5%), dispnea (3.2%), uġigħ addominali (2.7%), dijarea (2.7%), reazzjoni fis-sit tal-injezzjoni (2.2%), uġigħ ta' ras (2.0%), ipokalemija (1.7%) u raxx (1.7%).
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija ddefinita kif ġej: komuni ħafna (≥1/10);komuni (≥1/100 sa <1/10); u mhux komuni (≥1/1,000 sa <1/100).
English: • invasive aspergillosis
Maltese: • asperġillosi invażiva