FrancophonIA/ELRC3.0 huggingface dataset:
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Maltese: IU/kg) f'pazjenti tfal trattati qabel ta' età bejn 2 snin sa 5 snin b'emofilja A severa (n=13) Parametru PK
English: Bicalutamide Teva 150 mg Εpικaλυµµέν a µe λeptό υµένιο dιsκίa
Maltese: Bicalutamide Teva 150 mg Εpικaλυµµένa µe λeptό υµένιο dιsκίa
English: TEVA Classics S.A. 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
Maltese: 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 Franza
English: Jeneweinova 51a, 617 00 Brno, Czech Republic
Maltese: Jeneweinova 51a 617 00 Brno
English: TEVA Sweden AB PO Box 1070, SE - 25110
Maltese: TEVA Sweden AB PO Box 1070
English: Viale G. Richard 7, 20143 Milano Italy
Maltese: Richard 7, 20143 Milano L-Italja
English: Helsingborg Sweden
Maltese: Helsingborg L-Isvezja
English: Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
Maltese: TEVA Magyarország Rt Rákóczi út 70-72
English: Pharmachemie B.V. Swensweg 5, Postbus
Maltese: Pharmachemie B.V. Swensweg 5, Postbus 552 2003 RN Haarlem Olanda
English: 0.60 (0.49 to 0.73)
Maltese: 0.60 (0.49 sa 0.73)
English: 0.75 (0.61 to 0.91)
Maltese: 0.75 (0.61 sa 0.91)
English: No overall survival difference was seen at 7.4 years median follow-up with 22.9% mortality (HR = 0.99; 95% confidence interval 0.91 to 1.09).
Maltese: Ma ntweriet ebda differenza fis-sopravivenza globali wara 7.4 snin ta' sussegwirsi medjan b'mortalità ta' 22.9% (HR = 0.99; 95% intervall ta' kunfidenza 0.91 sa 1.09).
English: There was no significant difference in survival (HR=1.05 (CI=0.81-1.36), p=0.669) or in the interval until progression (HR=1.20 (CI 0.96-1.51), p=0.107) between the group treated with bicalutamide 150 mg and the group treated with castration.
Maltese: Ma kienx hemm differenza sinifikanti fis-sopravivenza (HR=1.05 (Intervall ta' kunfidenza, CI =0.81-1.36), p=0.669) jew flintervall sal-progressjoni (HR=1.20 (CI 0.96-1.51), p=0.107) bejn il-grupp ittrattat b'bicalutamide 150 mg u l-grupp ittrattat b'kastrazzjoni.
English: 0.56 (0.40 to 0.78)
Maltese: 0.56 (0.40 sa 0.78)
English: BicalutamidTeva 150 mg
Maltese: Bicalutamid-Teva 150 mg
English: Pharmacotherapeutic group: anti-androgens, ATC code: L02BB03
Maltese: Kategorija farmakoterapewtika: anti-androġen, Kodiċi ATC:
English: 3640 AE Mijdrecht The Netherlands
Maltese: Industrieweg 23, P.O. Box 217 3640 AE Mijdrecht Olanda
English: Bicalutamide 150 mg was studied as a treatment for patients with localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).
Maltese: Bicalutamide 150 mg ġie studjat bħala kura għal pazjenti b'kanċer mhux metastatiku lokalizzat (T1T2, N0 jew NX, M0) jew lokalment avvanzat (T3-T4, kull N, M0; T1-T2, N+, M0) tal-prostata, f'analiżi kombinata ta' 3 studji double-blind b'kontrolli bi plaċebo fuq 8,113-il pazjent, fejn il-prodott ġie mogħti bħala terapija ormonali immedjata jew bħala mizjuda ma' kura oħra għal prostatomija radikali jew radjuterapija (prinċipalment radjazzjoni b'raġġ estern).
English: At 7.4 years median follow-up, 27.4 % of all bicalutamide-treated patients and 30.7 % of all placebo-treated patients had experienced objective disease progression.
Maltese: Wara osservazzjoni segwenti fuq medda medjana ta' 7.4 snin, 27.4 % tal-pazjenti kollha trattati b'bicalutamide u 30.7 % tal-pazjenti kollha trattati bi plaċebo kellhom progressjoni oġġettiva tal-marda.
English: Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3,
Maltese: Lagoas Park, Edifício 1, Piso 3, 2740-264
English: Norway
Maltese: Il-Norveġja
English: A general trend with respect to quality of life in favour of bicalutamide 150 mg in comparison with castration was observed; the subgroups that provided these data showed significantly higher sexual appetence (p=0.029) and fitness (p=0.046).
Maltese: Xejra ġenerali fir-rigward tal-kwalità tal-ħajja favur bicalutamide 150 mg meta mqabbel ma' kastrazzjoni ġiet osservata; is-sottogruppi li pproduċew din id-dejta wrew ħajra sesswali (p=0.029) u forma fiżika (p=0.046) sinifikament ogħla.
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' Periklu (HR) (95% Intervall ta‘ kunfidenza)
English: Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
Maltese: Bicalutamide huwa anti-androġen mhux sterojdi mingħajr attivita endokrinali oħra.
English: It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
Maltese: Jista' jintuża f'kombinazzjoni ma' radjuterapija jew kirurġija tal-prostata fi programmi ta' trattamenti bikrija.
English: Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Maltese: Bicalutamide huwa racemate, li l-(R)-enantiomer tiegħu għandha l-biċċa l-kbira ta' l-attività antiandroġenika.
English: Combined analysis of 2 clinical studies comprising 805 patients with metastatic prostatic carcinoma, who had not been treated before with expected mortality 43%, showed that the treatment with bicalutamide 150 mg is less effective than castration as for the survival time (HR = 1.30 [confidence interval 1.04 - 1.65]).
Maltese: Analiżi kombinata f'2 studji kliniċi li kienu jikkonsistu f'805 pazjenti b'karċinoma metastatika talprostata, li ma ġewx ittrattati qabel b'mortalità mistennija ta' 43%, urew li t-trattament b'bicalutamide 150 mg huwa inqas effettiv minn kastrazzjoni rigward żmien ta' sopravivenza (HR = 1.30 [intervall ta' kunfidenza 1.04 - 1.65]).
English: The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
Maltese: Il-CHMP ikkonkluda li l-bilanċ tal-benefiċċju/riskju ta' bicalutamide 150 mg li fih prodotti mediċinali fl-indikazzjoni ristretta miftehema huwa wieħed favorevoli.
English: TEVA Pharma B.V., Industrieweg 23, P.O.
Maltese: Teva Pharma B.V.
English: The Committee, considering the Casodex Referral (bicalutamide 150 mg) made under article 31 of Directive 2001/83/EC for medicinal products containing bicalutamide, reached the conclusion that bicalutamide 150mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to: “Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression”.
Maltese: Il-Kumitat, wara li ħa kont tar-Referenza ta' Casodex (bicalutamide 150 mg) skond l-Artikolu 31 tadDirettiva 2001/83/KE dwar il-prodotti mediċinali li fihom bicalutamide, wasal għall-konklużjoni li bicalutamide 150mg huwa effettiv fil-kura ta' kanċer tal-prostata avvanzat lokalment, iżda il-CHMP ikkunsidra li l-indikazzjoni terapewtika għandha tkun ristretta għal: “Bicalutamide 150mg huwa indikat jew waħdu inkella flimkien ma' prostatektomija radikali jew radjoterapija f'pazjenti b'kanċer tal-prostatat avvanzat lokalment b'riskju kbir ta' progressjoni tal-marda”.
English: The applicant has applied for a Marketing Authorisation in several member states through the Mutual Recognition Procedure with Czech Republic as reference member state (RMS).
Maltese: L-applikant applika għal Awtorizzazzjoni għat-Tqegħid fis-Suq f'diversi stati membri permezz talProċedura għar-Rikonoxximent Reċiproku mar-Repubblika Ċeka bħala Stat Membru ta' referenza (RMS).
English: Events (%) in placebo patients
Maltese: Mewt (%) fuq pazjenti fuq plaċebo
English: - In addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include heart failure, hepatic failure, interstitial lung disease, breast cancer, and reports concerning pregnancy in partners of patients taking bicalutamide.
Maltese: - Flimkien ma' l-attivitajiet ta' rutina ta' farmakoviġilanza, riskji potenzjali identifikati u enfasizzati għal aktar monitoraġġ u tkomplija għandhom jinkludu l-kollass tal-qalb, ilkollass epatiku, il-mard interstizjali fil-pulmun, il-kanċer tas-sider u r-rapporti ta' tqala fis-sieħba tal-pazjent li jkun qed jieħdu bicalutamide.
English: Applicant
Maltese: Ġermanja
English: BicamidGRY 150 mg Filmtabletten
Maltese: Bicamid-GRY 150 mg Filmtabletten
English: BicalutamidTeva
Maltese: TA' L-EVALWAZZJONI
English: 2740-264 Porto Salvo, Portugal
Maltese: Porto Salvo Il-Portugall
English: Anti-androgens act against the effects of androgens (male sex hormones).
Maltese: Anti-androġeni jaġixxu kontra l-effetti ta' androġeni (ormoni sesswali tar-raġel).
English: 0.81 (0.66 to 1.01)
Maltese: 183/322 (56.8) 0.81 (0.66 sa 1.01)
English: The effectiveness of bicalutamide 150 mg in the treatment of patients with locally advanced prostatic carcinoma without metastases, for whom primary treatment with hormones was indicated, was evaluated separately using the meta-analysis of two studies comprising 480 patients with prostatic carcinoma without metastases (M0) who had not been treated before.
Maltese: L-effettvità ta' bicalutamide 150 mg fit-trattament ta' pazjenti b'karċinoma prostatika mingħajr metastasi lokalment avvanzata, li għalihom trattament prinċipali b'ormoni kien indikat, ġiet evalwata separatament permezz ta' meta-analiżi ta' żewġ studji li jikkonsistu minn 480 pazjent b'karċinoma prostatika mingħajr metastasi (M0) u li qatt ma ġew ittrattati qabel.
English: Table 2 Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in Bicalutamide patients
Maltese: Tabella 2 Sopravivenza globali f'mard avvanzat lokalment skond is-sottogrupp tat-terapija
English: Bicalutamide is an oral-androgen used in the management of locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Maltese: Bicalutamide huwa anti-androġen orali użat fittrattament lokali tal-kanċer tal-prostata fi stadju avvanzat, bħala terapija immedjata waħidha jew bħala addizzjoni għat-trattament permezz ta' prostatektomija radikali jew radjoterapija.
English: 1.09 (0.85 to 1.39)
Maltese: 122/849 (14.4) 1.09 (0.85 sa 1.39)
English: BicalutamideTEVA
Maltese: TAL-PRODOTT
English: 0.65 (0.44 to 0.95)
Maltese: 61/144 (42.4) 0.65 (0.44 sa 0.95)
English: However some trends were apparent for patients in exploratory subgroup analyses.
Maltese: Madankollu dehru xi xejriet għal pazjenti f'analiżi esploratorja fis-sottogrupp.
English: It binds to androgen receptors without activating gene expression and thus inhibits androgen stimulation.
Maltese: Huwa jingħaqad ma riċettaturi androġeni mingħajr ma jattiva l-espressjoni tal-ġene u għalhekk jimpedixxi listimulazzjoni androġenika.
English: Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Maltese: Pilloli Bicaluplex 150 mg huma indikati għal prostatomija radikali jew radjuterapija f'pazjenti b'kanċer lokali tal-prostata b'riskju għoli bi progressjoni tal-marda (ara sezzjoni 5.1), kemm weħedhom u kemm miżjuda ma' kura oħra .
English: The Article 29 referral procedure was initiated due to concerns raised by Germany on the potential serious risk to public health regarding the benefit/risk ratio of this product.
Maltese: Il-proċedura ta' referenza skond l'Artikolu 29 inbdiet minħabba t-tħassib li qajjmet ilĠermanja dwar il-possibilità ta' riskju serju potenzjali għas-saħħa pubblika fir-rigward tal-proporzjon ta' riskju/benefiċċju ta' dan il-prodott.
English: Bicaluplex 150 mg
Maltese: Bicaluplex 150 mg 150 mg Pillola miksija b'rita
English: Bicalutamide 150 mg Filmcoated
Maltese: Bicalutamide 150 mg Film-coated Tablets
English: Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Maltese: Għalhekk, ittobba għandhom mnejn jiddeċiedu li l-aħjar strateġija medika għal pazjent li jinsab f'riskju baxx ta' progressjoni tal-marda, b'mod partikolari fi sitwazzjoni fejn tingħata aktar min kura waħda wara prostatomija radikali, għandha mnejn tkun li t-terapija ormonali tiġi diferita sakemm jintwerew sinjali li l-marda qed tinfirex.
English: Strength Pharmaceutical form
Maltese: Prostatomija radikali
English: The scope of Bicaluplex Article 29 Referral concerns the benefit/risk ration of both indications: treatment of locally advanced prostatic cancer and monotherapy in early treatment or as adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostate cancer.
Maltese: L-iskop tar-Referenza skond l'Artikolu 29 dwar Bicaluplex tirrigwarda l-iskarsezza tar-razzjoni benefiċċju/riskju taż-żewġ indikazzjonijiet: il-kura tal-kanċer tal-prostata avvanzat lokalment u monoterapija fil-kura bikrija jew bħala żjieda għall-kura bir-radjoterapija jew prostatektomija radikali f'pazjenti li għandhom kanċer fil-prostata.
English: Tablets
Maltese: TIKKETTAR
English: Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s.r.o.)
Maltese: Bicalutamide 150mg pilloli miksijin b'rita (Ingers Industrial Solutions s.r.o) huma preparazzjonijiet ġeneriċi li fihom bicalutamide bħala s-sustanza attiva.
English: The bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
Maltese: Il-bijoekwivalenza bejn il-prodotti ta' referenza u dawk ittestjati ġiet ippruvata b'mod suffiċjenti u ma ġietx iddubitata waqt din ir-referenza.
English: A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Maltese: Deher tnaqqis fir-riskju ta' progressjoni oġġettiva tal-marda fuq ħafna mill - gruppi ta' pazjenti imma li kienet l-aktar evidenti fuq dawk li jinsabu fl-ogħla riskju ta' progressjoni tal-marda.
English: Table 1 Progression-free survival in locally advanced disease by therapy sub-group Analysis population Events (%) in Bicalutamide patients
Maltese: Tabella 1 Sopravivenza mingħajr firxa f'mard lokalment avvanzat skond is-sottogrupp tat-terapija
English: National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: FIS-SUQ L-Awtoritajiet Kompetenti Nazzjonali, immexxija mill-Istat Membru ta' Referenza (RMS), għandhom jiżguraw li d-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jissodisfaw dawn il-kondizzjonijiet li ġejjin:
English: WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR Bicalutamide belongs to the group of anti-androgens.
Maltese: Bicalutamide jappartjeni għall-grupp ta' anti-androġeni.
English: Inhibition results in the regression of prostatic tumours.
Maltese: L-impediment jirriżulta f'rigressjoni ta' tumuri prostatiċi.
English: In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16, 95% CI 0.99 to 1.37).
Maltese: (HR=1.16, 95% Intervall ta' kunfidenza 0.99 sa 1.37).
English: TEVA PharmaProdutos
Maltese: TEVA Pharma - Produtos Farmacêuticos Lda
English: The estimated difference is 42 days while the mean survival time is 2 years.
Maltese: Id-differenza stmata hi ta' 42 jum filwaqt li ż-żmien medju ta' sopravivenza hu ta' sentejn.
English: Ref. EMEA/287136/2008
Maltese: EMEA/381427/2007
English: London, 21 June 2007 Doc.
Maltese: Londra, 21 ta' Ġunju 2007 Doc.
English: International non-proprietary name (INN): glucarpidase
Maltese: Denominazzjoni Komuni Internazzjonali (INN): glucarpidase
English: What is Voraxaze?
Maltese: X'inhu Voraxaze?
English: It contains the active substance glucarpidase.
Maltese: Fih is-sustanza attiva glucarpidase.
English: The studies in human involved a total of 222 patients in two main studies.
Maltese: L-istudji fl-umani involvew total ta' 222 pazjent f'żewġ studji prinċipali.
English: The active substance in Voraxaze, glucarpidase, is a copy of the naturally-occurring enzyme carboxypeptidase G2. Carboxypeptidase G2 was originally found in a Pseudomonas bacterium.
Maltese: Is-sustanza attiva f'Voraxaze, glucarpidase, hija kopja ta' l-enzim li jseħħ b'mod naturali carboxypeptidase G2. Carboxypeptidase G2 oriġinarjament instab f'Pseudomonas bacterium.
English: The recombinant enzyme acts in the same way as the natural carboxypeptidase G2.
Maltese: Lenzim rikombinanti jaġixxi bl-istess mod bħal carboxypeptidase G2 naturali.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni ta' l-applikazzjoni qabel ma ġiet irtirata?
English: Some cancer patients receive high doses, and, because of this, can experience toxic effects, such as damage to the kidneys, bone marrow suppression (leading to anaemia, an increased risk of infection and bleeding) and mucositis (an inflammation of the mucosa, the lining of organs such as the mouth, with soreness, redness and ulceration).
Maltese: Xi pazjenti morda bil-kanċer jirċievu dożi għoljin, u minħabba f'hekk, jistgħu jesperjenzaw effetti tossiċi, bħal ħsara fil-kliewi, suppressjoni tal-mudullun ta' l-għadam (li jwassal għal anemija, riskju miżjud ta' infezzjoni u fsada) u mukożite (infjammazzjoni tal-mukosa, ir-rita ta' organi bħalma huwa l-ħalq, b'uġigħ, ħmura u ulċeri).
English: The glucarpidase in Voraxaze is made by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Maltese: Glucarpidase f'Voraxaze jiġi prodott b'metodu magħruf bħala teknoloġija 'rikombinanti tad-DNA': huwa magħmul minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċih.
English: Methotrexate is used to treat a number of diseases, including some types of cancer.
Maltese: Methotrexate jintuża biex jittratta numru ta' mard, inkluż tipi ta' kanċer.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Il-CHMP normalment jieħu sa 210 jiem biex jivvaluta applikazzjoni ġdida.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun provdiet it-tweġibiet kollha għall-mistoqsijiet, il-CHMP jirrivedihom u jista', qabel jagħti opinjoni, jsaqsi xi mistoqsijiet oħra fil-jum 180.
English: Because the number of patients with this condition is low, it is considered ‘rare', and glucarpidase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 February 2003.
Maltese: Billi l-għadd ta' pazjenti li jbatu minn din il-kundizzjoni huwa wieħed baxx, il-marda hi meqjusa 'rari' u glucarpidase ġie kklassifikat bħala 'mediċina orfni' (mediċina użata fil-mardiet rari) fit-3 ta' Frar
English: On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Maltese: Fil-21 ta' Mejju 2007, Protherics PLC innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) li huma jixtiequ jirtiraw l-applikazzjoni tagħhom għal awtorizzazzjoni għat-tqegħid fis-suq għal Voraxaze, għat-trattament addizzjonali ta' pazjenti li qegħdin jesperjenzaw jew li huma f'riskju ta' tossiċità b'methotrexate.
English: The effects of Voraxaze were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Voraxaze għall-ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati filbniedem.
English: The main concerns of the CHMP were related to the manufacture of Voraxaze.
Maltese: Għal x'hiex huwa mistenni li jintuża Voraxaze?
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, il-CHMP iħejji lista ta' mistoqsijiet fil-jum 120, li tintbagħat lillkumpanija.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li l-CHMP ivvaluta t-tweġibiet mill-kumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet mhux solvuti pendenti.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Voraxaze?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għall-pazjenti li kienu qed jieħdu sehem fi studji kliniċi / programmi ta' użu ta' kompassjoni b'Voraxaze?
English: Voraxaze was to be used as an add-on treatment in patients already receiving a medicine, methotrexate, to prevent or treat the toxic effects of methotrexate.
Maltese: Dan it-trattament jimpedixxi jew jittratta l-effetti tossiċi ta' methotrexate.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Voraxaze could not have been approved for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Maltese: Dan jgħin lill-ġisem jelimina lmethotrexate żejjed, u għalhekk inaqqas il-potenzjal għal effetti tossiċi.
English: Another medicine, folinic acid, is often given after the methotrexate to help control the toxicities (‘rescue' treatment) but these may still develop despite the rescue treatment.
Maltese: Mediċina oħra, aċidu foliniku, tingħata spiss wara methotrexate biex tgħin tikkontrolla t-tossiċitajiet (trattament ta' ‘salvataġġ'), madankollu dawn xorta waħda jistgħu jiżviluppaw minkejja t-trattament ta' salvataġġ.
English: This summary was last updated in March 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar Marzu 2012.
English: Oxyglobin contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml), which belongs to a class of medicines having an oxygen-carrying action.
Maltese: Oxyglobin fih haemoglobin glutamer-200 bovin (b'qawwa ta' 130 mg/ml), li jappartieni għallkategorija ta' mediċini li għandhom azzjoni ta' ġarr ta' ossiġenu.
English: Oxyglobin is a solution for infusion (drip into a vein).
Maltese: Oxyglobin huwa soluzzjoni għal infużjoni (drip fil-vina).
English: Oxyglobin is first warmed to 37°C, then given to the dog as 30 ml per kilogram body weight, administered at a rate of up to 10 ml/kg per hour.
Maltese: Oxyglobin l-ewwel jissaħħan għal 37°C, imbagħad jingħata lil kelb bħala 30 ml għal kull kilogramma tal-piż korporali, mogħti b'rata ta' mhux aktar minn 10 ml/kg fis-siegħa.
English: In the main study in dogs, 95% of the animals treated with Oxyglobin needed no other type of oxygen-carrying treatment after 24 hours, compared with 32% of the dogs that did not receive any treatment.
Maltese: Fl-istudju prinċipali fuq il-klieb, 95% ta' l-annimali trattati b'Oxyglobin ma ħtieġu ebda tip ieħor ta' trattament li jġorr l-ossiġenu wara 24 siegħa, meta mqabbla ma' 32% tal-klieb li ma rċevew ebda trattament.
English: A common side effect is ‘circulatory overload' (when the blood fluid leaks out of the blood vessels), which causes tachypnea (rapid breathing), dyspnea (shortness of breath), harsh lung sounds and pulmonary oedema (fluid accumulation in the lungs).
Maltese: Effett sekondarju komuni huwa ‘overload ċirkolatorja' (meta l-fluwidu tad-demm inixxi mill-vini), li jikkawża takipneja (teħid ta' nifs qawwi), dispnea (qtugħ ta' nifs), ħsejjes ħorox fil-pulmun u edema pulmonari (akkumulazzjoni tal-fluwidi fil-pulmun).