FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Bevespi Aerosphere are continuously monitored.
Maltese: Aerosphere hija ssorveljata kontinwament.
English: Bevespi Aerosphere is used for maintenance (regular) treatment.
Maltese: Aerosphere jintuża għall-kura ta' manutenzjoni (regolari).
English: Finally, the studies showed that Bevespi Aerosphere can lead to modest improvements in symptoms such as breathlessness.
Maltese: Aerosphera jista' jwassal għal titjib modest fis-sintomi bħallnuqqas ta' nifs.
English: How is Bevespi Aerosphere used?
Maltese: Aerosphere li ħarġu mill-istudji?
English: The two active substances in Bevespi Aerosphere work in different ways to widen the airways and improve breathing in COPD.
Maltese: Aerosphere jaħdmu b'modi differenti biex iwessgħu l-passaġġi tal-arja u jtejbu n-nifs għal minn għandu s-COPD.
English: EMA/HMPC/411665/2008 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FOENICULUM VULGARE MILLER SUBSP.
Maltese: EMA/HMPC/411665/2008 KUMITAT GĦALL-PRODOTTI MEDIĊINALI ERBALI
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: mail@emea.europa.eu http://www.emea.europa.eu© European Medicines Agency, 2010.
Maltese: (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51
English: VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS FENNEL FRUIT, SWEET HMPC Assessment Report Summary for the Public
Maltese: VAR. DULCE (MILLER) THELLUNG, FRUCTUS FROTTA TAL-BUŻBIEŻ, ĦELU Sommarju tar-Rapport ta' Valutazzjoni tal-HMPC għall-Pubbliku
English: These combination medicines will be assessed separately by the HMPC.
Maltese: Dawn il-mediċini ta' kombinazzjoni se jiġu valutati separatament millHMPC.
English: IMPORTANT NOTE: The image is provided to give additional information on the source of the herbal substance/preparation.
Maltese: L-istampa hija pprovduta għal finijiet ta' informazzjoni addizzjonali dwar is-sors tas-sustanza/tal-preparazzjoni erbali.
English: The botanical Latin name of the plant is Foeniculum vulgare Miller subsp.
Maltese: L-isem botaniku bil-Latin tax-xitla huwa Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.
English: For further information, see section ‘Specified posology of the Community list entry on sweet fennel fruit.
Maltese: Għal aktar informazzjoni ara s-sezzjoni ‘Pożoloġija speċifikata tal-lista Komunitarja dwar il-frotta tal-bużbież ħelu'.
English: - symptomatic treatment of minor spasm (cramps) associated with menstrual periods.
Maltese: - għat-trattament sintomatiku tal-ispażmi minuri (uġigħ) assoċjati miċ-ċikli mestrwali.
English: A relaxing effect on isolated contracted smooth muscles of alcoholic extracts of fennel and fennel essential oil has been reported.
Maltese: Ġie rrappurtat effett rilassanti fuq il-muskoli lixxi kontratti iżolati ta' estratti alkoħoliċi tal-bużbież u taż-żejt essenzjali tal-bużbież.
English: Sweet fennel fruit medicines are available in various forms to be taken by mouth, such as herbal tea, tablets, capsules.
Maltese: Il-mediċini tal-frotta tal-bużbież ħelu huma disponibbli f'varji forom biex jittieħdu mill-ħalq, bħal tejiet, pilloli u kapsuli erbali.
English: Clinical trials on sweet fennel fruit medicines are limited, but pharmacological data support the plausibility of the traditional medicinal use.
Maltese: Il-provi kliniċi fuq il-mediċini tal-frotta tal-bużbież ħelu huma limitati iżda d-dejta farmakoloġika tikkorrobora l-plawsibbiltà tal-użu mediċinali tradizzjonali.
English: Sweet fennel fruit medicines are traditionally used for: - symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
Maltese: Tradizzjonalment, il-mediċini tal-frott tal-bużbież ħelu jintużaw f'dawn il-każijiet: - għat-trattament sintomatiku ta' disturbi gastrointestinali spasmodiċi ħfief, fosthom nefħa u flatulenza.
English: The relaxing and anti-inflammatory effects together with the antimicrobial action of their constituents may contribute to the traditional use of sweet fennel medicines in the treatment of minor spasmodic gastro-intestinal complaints and in the treatment of cough associated with colds.
Maltese: L-effett rilassanti u antinfjammatorju flimkien mal-azzjoni antimikrobika tal-komponenti tagħhom jistgħu jikkontribwixxu fl-użu tradizzjonali tal-mediċini tal-bużbież ħelu fit-trattament taddisturbi gastrointestinali spasmodiċi minuri u fit-trattament tas-sogħla assoċjata mal-irjiħat.
English: The Commission decision establishing the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products can be found here.
Maltese: Id-Deċiżjoni tal-Kummissjoni li tistabbilixxi l-lista Komunitarja ta' sustanzi erbali, preparazzjonijiet erbali u kombinazzjonijiet tagħhom għal użu fi prodotti mediċinali erbali tradizzjonali tista' tiġi kkonsultata hawn.
English: It was has been observed that a number of compounds detected in fennel fruit inhibit the growth of pathogenic bacteria and fungi.
Maltese: Ġie osservat li għadd ta' komponenti misjuba fil-frotta tal-bużbież jinibixxu t-tkabbir ta' batterji u fungi patoġeni.
English: This document is a summary of the assessment report adopted by the Committee on Herbal Medicinal Products (HMPC) that describes the data available on the medicinal use of a herbal substance and the conclusions after evaluating these data.
Maltese: Dan id-dokument huwa sommarju tar-rapport ta' valutazzjoni adottat mill-Kumitat għall-Prodotti Mediċinali Erbali (HMPC) li jiddeskrivi d-dejta disponibbli dwar l-użu mediċinali ta' sustanza erbali u l-konklużjonijiet wara l-evalwazzjoni ta' din id-dejta.
English: The long-standing use over more than 30 years and limited experimental studies make the traditional use in the above-mentioned indications plausible.
Maltese: L-użu fit-tul għal 'il fuq minn 30 sena u l-istudji sperimentali limitati jagħmlu plawsibbli l-użu tradizzjonali fl-indikazzjonijiet hawn fuq imsemmija.
English: Furthermore, the secretolytic and expectorant effect of two main components of sweet fennel fruit (anethole and estragole) observed in a study conducted in rabbits, could also support the plausibility of the traditional use of fennel in cough associated with colds.
Maltese: Barra minn hekk, l-effett sekretolitiku u espettoranti ta' żewġ komponenti ewlenin tal-frotta tal-bużbież ħelu (anethole u estragole) osservat fi studju mwettaq fuq il-fniek, jistgħu wkoll jikkorroboraw ilplawsibbiltà tal-użu tradizzjonali tal-bużbież fis-sogħla assoċjata mal-irjiħat.
English: Important information on the use of a traditional herbal medicine can be found in the package leaflet that comes with each individual product.
Maltese: Informazzjoni importanti dwar l-użu ta' mediċina erbali tradizzjonali hija disponibbli fil-fuljett ta' tagħrif li jakkumpanja kull prodott individwali.
English: What are the risks associated with sweet fennel fruit medicines?
Maltese: Liema huma r-riskji assoċjati mal-mediċini tal-frotta tal-bużbież ħelu?
English: vulgare var. dulce (Miller) Thellung is provided in the HMPC Assessment Report, overview of comments received during the public consultation period and other related documents which can be found here.
Maltese: Aktar tagħrif dwar il-valutazzjoni tal-HMPC għall-Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung huwa disponibbli fir-Rapport ta' Valutazzjoni tal-HMPC, fir-rassenja talkummenti rċevuti waqt il-perjodu tal-konsultazzjoni pubblika u f'dokumenti relatati oħra li jistgħu jiġu kkonsultati hawn.
English: Many traditional herbal medicines have not been fully investigated with current scientific methods.
Maltese: Ħafna mediċini erbali tradizzjonali ma ġewx investigati bis-sħiħ bil-metodi xjentifiċi attwali.
English: The HMPC came to these conclusions after assessment of the bibliographic data available on sweet fennel fruit preparations.
Maltese: L-HMPC wasal għal dawn il-konklużjonijiet wara valutazzjoni tad-dejta bibljografika disponibbli għall-preparazzjonijiet tal-frotta tal-bużbież ħelu.
English: Further information on the HMPC assessment on Foeniculum vulgare Miller subsp.
Maltese: (HPMC) FOENICULUM
English: The active substance of Myoson is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Maltese: Is-sustanza attiva ta' Myoson hija idroklorur tat-tolperison li hija rilassant tal-muskoli b'azzjoni ċentrali indikat għal kura sintomatika ta' spastiċità fl-adulti wara puplesija.
English: The marketing authorisation application (MAA) for Myoson was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Maltese: L-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq (MAA) għal Myoson ġiet sottomessa skont l-Artikolu 10(1) tadDirettiva 2001/83/KE (jiġifieri applikazzjoni ġenerika), fil-konfront tal-prodott mediċinali ta' referenza Mydeton (Gedeon Richter Plc).
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Myoson 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Maltese: • Il-Kumitat kien tal-fehma li r-riżultati tal-istudji dwar il-bijoekwivalenza sottomessi wrew li l-pilloli Myoson 50 u 150 mg huma bijoekwivalenti għall-prodott mediċinali ta' referenza Mydeton 50 u 150 mg pilloli f'kundizzjonijiet ta' sawm;
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Myoson 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Maltese: Għalhekk, abbażi tar-riżultati tal-istudji dwar il-bijoekwivalenza sottomessi, il-membri tas-CHMP qablu li l-pilloli ta' 50 u 150 mg ta' Myoson huma bijoekwivalenti għall-prodott mediċinali ta' referenza Mydeton 50 u 150 mg pilloli (Gedeon Richter Plc) f'kundizzjonijiet ta' sawm.
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Myoson included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Maltese: Peress li s-sommarju tal-karatteristiċi tal-prodott (SmPC) tal-prodott mediċinali ta' referenza ma għamel ebda rakkomandazzjoni fir-rigward tal-ikel u ma għamilx referenza għall-effett tal-ikel, l-MAA li kienet sottomessa għal Myoson inkludiet żewġ studji ta' bijoekwivalenza b'pilloli miksijin b'rita ta' tolperison ta' 50 u 150 mg imwettqa f'kundizzjonijiet ta' sawm bi 52 voluntier kull wieħed.
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Myoson and associated names (see Annex I).
Maltese: Is-CHMP irrakkomanda l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq li għaliha, is-sommarju talkaratteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp ta' Koordinazzjoni, għal Myoson u ismijiet assoċjati (ara Anness I).
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Myoson contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Maltese: • Għalhekk, il-Kumitat ikkonkluda b'maġġoranza li l-istudji ta' bijoekwivalenza li saru fl-istat sajjem jagħtu biżżejjed evidenza biex tinstilet konklużjoni dwar il-bijoekwivalenza anki fl-istat mitmugħ peress li Myoson fih sustanza attiva li tinħall ħafna u hija permeabbli ħafna, u l-prinċipji farmakokinetiċi u l-evidenza sperimentali konvinċenti jissuġġerixxu li l-effett tal-ikel ta' din issustanza attiva ma jiddependix fuq il-formulazzjoni.
English: Stage 1a
Maltese: Stadju 1a
English: HR (95% CI)
Maltese: HR (CI ta' 95%)
English: Bendamustine N=166
Maltese: N=166
English: 82377 Penzberg GERMANY
Maltese: 82377 Penzberg IL-ĠERMANJA
English: 1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone.
Maltese: 1100 mg prednisone/prednisolone jew 20 mg dexamethasone jew 80 mg methylprednisolone.
English: Insomnia, depression, anxiety
Maltese: Insomnja, depressjoni, ansjetà
English: Cycle 1:
Maltese: Ċiklu 1:
English: 11.6% of the patients had marginal zone lymphoma (MZL) and 7.1% had small lymphocytic lymphoma (SLL).
Maltese: 11.6% tal-pazjenti kellhom limfoma taż-żona marġinali (MZL - marginal zone lymphoma) u 7.1% kellhom limfoma limfoċitika żgħira (SLL - small lymphocytic lymphoma).
English: CLL only - Cycle 1
Maltese: CLL biss - Ċiklu 1
English: Cycles 2 - 6
Maltese: Ċikli 2 - 6
English: Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
Maltese: Kortikosterojdi fil-vini1,4 (obbligatorji għal CLL, rakkomandati għal FL)
English: Intravenous corticosteroid1 (mandatory)
Maltese: Kortikosterojdi fil-vini1 (obbligatorji)
English: Cycles 2-6
Maltese: Ċikli 2-6
English: No significant difference was observed in the pharmacokinetics of obinutuzumab among patients < 65 years (n=375), patients between 65-75 years (n=265) and patients > 75 years (n=171).
Maltese: Ma kienet osservata l-ebda differenza sinifikanti filfarmakokinetika ta' obinutuzumab fost pazjenti b'età ta' < 65 sena (n=375), pazjenti bejn 65-75 sena (n=265) u pazjenti > 75 sena (n=171).
English: Anaemia, leukopenia
Maltese: Anemija, lewkopenija
English: · Store in a refrigerator (2 °C-8 °C).
Maltese: • Aħżen fi friġġ (2°C - 8°C).
English: The majority of patients had follicular lymphoma (81%).
Maltese: Il-maġġoranza talpazjenti kellhom limfoma follikulari (81%).
English: Intravenous corticosteroid1,4
Maltese: Kortikosterojdi fil-vini1,4
English: For subgroups, reduction of the risk of disease progression or death ranged from 92% to 58% for GClb versus Clb and 72% to 29% for GClb versus RClb.
Maltese: Għas-sottogruppi, tnaqqis fir-riskju ta' progressjoni tal-marda jew mewt varja minn 92% sa 58% għal GClb kontra Clb u 72% sa 29% għal GClb kontra RClb.
English: The observed HRs by chemotherapy subgroup were as follows; CHOP (n = 398): HR 0.77 (95% CI: 0.50, 1.20), CVP (n = 118): HR 0.63 (95% CI: 0.32, 1.21), and bendamustine (n = 686): HR 0.61 (95% CI: 0.43, 0.86).
Maltese: HR 0.63 (CI ta' 95%: 0.32, 1.21), u bendamustine (n = 686): HR 0.61 (CI ta' 95%: 0.43, 0.86).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Lulju 2014
English: Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype.
Maltese: Obinutuzumab huwa antikorp rikombinanti monoklonali umanizzat glycoengineered Tip II kontra CD20 tal-isotip IgG1.
English: HistidineHistidine hydrochloride monohydrate Trehalose dihydrate
Maltese: Histidine hydrochloride monohydrate Trehalose dihydrate Poloxamer 188
English: Each cycle lasts 28 days.
Maltese: Kull ċiklu jdum 28 jum.
English: System organ class Frequency
Maltese: Klassi tas-sistemi u tal-organi
English: Gastro-Intestinal Perforation
Maltese: Perforazzjoni Gastrointestinali
English: During the maintenance period in study GAO4753g/GADOLIN, the most common adverse reactions were cough (15%), upper respiratory infections (12%), neutropenia (11%), sinusitis (10%), diarrhoea (8%), IRRs (8%), nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%).
Maltese: Matul il-perjodu ta' manteniment fi studju GAO4753g/ GADOLIN, l-aktar reazzjonijiet avversi komuni kienu sogħla (15%), infezzjonijiet fl-apparat respiratorju ta' fuq (12%), newtropenija (11%), sinożite (10%), dijarea (8%), IRRs (8%), dardir (8%), għeja (8%), bronkite (7%), artralġja (7%), deni (6%), nażofarinġite (6%), u infezzjonijiet fl-apparat tal-awrina (6%).
English: · The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections.
Maltese: • L-eċċipjenti l-oħra huma histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 u ilma għall-injezzjonijiet.
English: * Chemotherapy: Chlorambucil in CLL; bendamustine, CHOP, CVP in iNHL including FL § observed also during maintenance treatment with at least 2% higher incidence in Gazyvaro arm (BO21223)
Maltese: Chlorambucil f'CLL; bendamustine, CHOP, CVP f'iNHL inkluża FL § osservata wkoll matul trattament ta' manteniment b'inċidenza mill-inqas 2% ogħla fil-grupp ta' Gazyvaro (BO21223)
English: Day of treatment
Maltese: Tul tat-trattament
English: A post hoc analysis was performed 8 months after the primary analysis data cut.
Maltese: Twettqet analiżi post hoc 8 xhur wara li waqfet tinġabar id-dejta tal-analiżi primarja.
English: Primary Endpoint
Maltese: Punt finali primarju
English: Rituximab + Chemotherapy followed by rituximab maintenance N=601
Maltese: Rituximab + Kimoterapija segwit minn rituximab bħala manteniment N=601
English: Fatal infections have been reported.
Maltese: Kienu rrappurtati infezzjonijiet fatali.
English: In the pivotal studies in iNHL up to 1% of patients experienced gastrointestinal perforation.
Maltese: Fl-istudji pivitali dwar iNHL sa 1%tal-pazjenti kellhom perforazzjoni gastrointestinali.
English: Hypersensitivity may be difficult to clinically distinguish from IRRs.
Maltese: Jista' jkun diffiċli biex sensittività eċċessiva tiġi klinikament distinta minn IRRs.
English: The subgroups evaluated included IPI, FLIPI, Bulky Disease, B Symptoms at baseline, Ann Arbor Stage and ECOG at baseline.
Maltese: Is-sottogruppi evalwati kienu jinkludu IPI, FLIPI, Marda b'Massa Kbira, Sintomi B fil-linja bażi, Stadju Ann Arbor u ECOG fil-linja bażi.
English: In study BO21223/GALLIUM, 1/565 patient (0.2% of patients with a post-baseline assessment) developed HAHA at induction completion.
Maltese: BO21223/GALLIUM, 1/565 pazjent (0.2% tal-pazjenti b'evalwazzjoni wara l-linja bażi) żviluppa
English: Pharmacokinetics of obinutuzumab in patients with mild creatinine clearance (CrCl 50-89 mL/min, n=464) or moderate (CrCl 30 to 49 mL/min, n=106) renal impairment were similar to those in patients with normal renal function (CrCl ³ 90 mL/min, n=383).
Maltese: Il-farmakokinetika ta' obinutuzumab f'pazjenti bi tneħħija tal-krejatinina ħafifa (CrCl 50-89 mL/min, n=464) jew b'indeboliment renali moderat (CrCl 30 sa 49 mL/min, n=106) kienet simili għal dik f'pazjenti b'funzjoni renali normali (CrCl ≥ 90 mL/min, n=383).
English: HR (95% CI) p-value (Log-Rank test, stratified*)
Maltese: HR (CI ta' 95%) Valur p (test Log-Rank, stratifikat*)
English: At baseline, 22% of patients had Binet Stage A, 42% had Binet Stage B and 36% had Binet Stage C.
Maltese: Fil-linja bażi, 22% tal-pazjenti kellhom Binet Stadju A, 42% kellhom Binet Stadju B u 36% kellhom Binet Stadju Ċ.
English: decrease in potassium
Maltese: tnaqqis fil-potassium
English: Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Maltese: Gazyvaro + Kimoterapija segwit minn Gazyvaro bħala manteniment N=601
English: Previously untreated follicular lymphoma (study BO21223/GALLIUM)
Maltese: Limfoma follikulari Limfoma follikulari mhux ittrattata minn qabel (studju BO21223/GALLIUM)
English: In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B-cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
Maltese: BO21004/CLL11, 91% (40 minn 44) tal-pazjenti li setgħu jiġu evalwati kkurati b'Gazyvaro kellhom nuqqas ta' ċelluli B (definit bħala għadd ta' ċelluli B CD19+ < 0.07 x 109/L) fl-aħħar tal-perjodu ta' kura u baqgħu hekk matul l-ewwel 6 xhur ta' segwitu.
English: The combination of obinutuzumab with chlorambucil, bendamustine, CHOP or CVP may increase the risk of neutropenia (see section 4.4).
Maltese: Il-kombinazzjoni ta' obinutuzumab ma' chlorambucil, bendamustine, CHOP jew CVP tista' iżżid irriskju ta'newtropenija (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/937/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/937/001
English: · infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough
Maltese: • Infezzjoni fil-passaġġi respiratorji ta' fuq (infezzjoni fl-imnieħer, farinġi, larinġi u sinusis), sogħla
English: Obinutuzumab is not a substrate, inhibitor, or inducer of cytochrome P450 (CYP450), uridine diphosphate glucuronyltransferase (UGT) enzymes and transporters such as P-glycoprotein.
Maltese: Obinutuzumab mhux sottostrat, inibitur, jew induttur tal-enzimi taċ-ċitokromju P450 (CYP450), enzimi uridine diphosphate glucuronyltransferase (UGT) u trasportaturi bħal glikoproteina p. Għalhekk, mhux mistennija interazzjoni farmakokinetika ma' prodotti mediċinali magħrufa li huma metabolizzati minn dawn is-sistemi ta' enzimi.
English: Kaplan-Meier curves for progression-free survival (PFS) and Overall Survival (OS) are shown in Figures 1-4.
Maltese: Kurvi Kaplan-Meier għas-sopravivenza mingħajr progressjoni (PFS - progression free survival) u s-Sopravivenza Globali (OS - Overall Survival) huma murija f'Figuri 1-4.
English: Patients in the CLL pivotal study BO21004/CLL11 were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Gazyvaro.
Maltese: Pazjenti fl-istudju pivitali dwar CLL BO21004/CLL11 kienu ttestjati f'bosta punti ta' żmien għallantikorpi antiterapewtiċi (ATA - anti-therapeutic antibodies) għal Gazyvaro.
English: Cycle 1: Day 1 for CLL and FL
Maltese: Jum 1 għal CLL u FL
English: In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, 5% (35 out of 698) and 8% (15 out of 194) of patients treated with Gazyvaro, respectively, had moderate renal impairment (CrCL < 50 mL/min).
Maltese: Fl-istudji pivitali (BO21223/GALLIUM, GAO4753g/GADOLIN) dwar iNHL, 5% (35 minn 698) u 8% (15 minn 194) tal-pazjenti ttrattati b'Gazyvaro, rispettivament, kellhom indeboliment renali moderat (CrCL < 50 mL/min).
English: In a phase III, open label, multicentre, randomised clinical study (BO21223/GALLIUM), 1202 patients with previously untreated Grade 1-3a advanced (stage II bulky disease, stage III/IV) FL were evaluated.
Maltese: III, open label, b'aktar minn ċentru wieħed u randomised (BO21223/GALLIUM), ġew evalwati 1202 pazjent b'FL avanzata ta' Grad 1-3a (marda fi stadju II b'massa kbira, stadju III/IV) mhux ittrattata minn qabel.
English: Findings included acute anaphylactic or anaphylactoid reactions and an increased prevalence of systemic inflammation and infiltrates consistent with immune-complex mediated hypersensitivity reactions, such as arteritis/periarteritis, glomerulonephritis, and serosal/adventitial inflammation.
Maltese: Sejbiet inkludew reazzjonijiet anafilattiċi jew anafilattojdi akuti u prevalenza akbar ta' infjammazzjoni sistemika u infiltrati konsistenti ma 'reazzjonijiet ta' sensittività eċċessiva medjati minn kumpless immuni, bħal arterite/periarterite, glomerulonefrite, u infjammazzjoni serosali/adventizjali.
English: Standard dosing of CHOP and CVP was given.
Maltese: Ingħata dożaġġ standard ta' CHOP u CVP.
English: Gazyvaro can then be used on its own for up to 2 years as a “maintenance treatment”.
Maltese: Gazyvaro imbagħad jista' jintuża waħdu sa 2 snin bħala “trattament ta' manteniment”.
English: A total of 781 patients were randomised 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone.
Maltese: Total ta' 781 pazjent kienu randomised 2:2:1 biex jirċievu Gazyvaro flimkien ma 'chlorambucil, rituximab flimkien ma 'chlorambucil jew chlorambucil waħdu.
English: The majority of patients were Caucasian (95%) and male (61%).
Maltese: Ilmaġġoranza tal-pazjenti kienu Kawkasi (95%) u rġiel (61%).