FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandimmun Neoral was first registered in Germany in February 1993 and is available in the EU as 10 mg, 25 mg, 50 mg, 100 mg soft gelatin capsules and 100 mg/ml oral solution.
Maltese: bħala kapsuli tal-ġelatina ratba ta' 10 mg, 25 mg, 50 mg, 100 mg u soluzzjoni orali ta' 100 mg/ml.
English: The CHMP is of the opinion that the available data confirms the use of ciclosporin in the following indication: “Treatment of severe, active rheumatoid arthritis.”
Maltese: Is-CHMP huwa tal-fehma li d-dejta disponibbli tikkonferma lużu ta' ciclosporin fl-indikazzjoni li ġejja: “Kura ta' artrite rewmatika attiva, severa.
English: The MAH proposed wordings for the sub-sections “Absorption, Distribution, Biotransformation and Elimination, Special populations and Paediatric population.” based on a harmonized text already approved in 13 EU countries.
Maltese: Eliminazzjoni, Popolazzjonijiet speċjali u Popolazzjoni pedjatrika" abbażi ta' test armonizzat diġà approvat fi 13-il pajjiż tal-UE.
English: As a consequence of these additional advantages, Sandimmun Neoral can be administered independently of mealtimes.
Maltese: B'konsegwenza ta' dawn il-vantaġġi addizzjonali, Sandimmun Neoral jista' jingħata indipendentement mill-ħin tal-ikel.
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun Neoral and associated names.
Maltese: Bħala konklużjoni, abbażi tal-valutazzjoni tal-proposta tal-MAH, it-tweġibiet għal-LoQ, il-LoOI u wara d-diskussjonijiet tal-kumitat, is-CHMP qabel dwar u adotta settijiet armonizzati ta' dokumenti tal-PI għad-diversi preżentazzjonijiet ta' Sandimmun Neoral u ismijiet assoċjati.
English: The MAH's proposed indication wording for the uveitis and Behçet uveitis is approved in 14 EU countries.
Maltese: Il-kliem tal-indikazzjoni propost mill-MAH għall-uveite u l-uveite ta' Behçet huwa approvat f'14-il pajjiż tal-UE.
English: The MAH proposed wordings for the sub-sections Summary of the safety profile, Doses/side effects, Infections and infestations and Neoplasms, Other ADRs from post-marketing experience.
Maltese: Il-MAH ippropona kliem għas-sottosezzjonijiet Sommarju tal-profil ta' sigurtà, Dożi/effetti sekondarji, Infezzjonijiet u infestazzjonijiet u Neoplażmi, ADRs oħra mill-esperjenza ta' wara ttqegħid fis-suq.
English: In the original Sandimmun studies, initial doses in the range 14-18 mg/kg/day have been used and these were subsequently reduced to a maintenance dose in the range 6-10 mg/kg/day.
Maltese: Fl-istudji oriġinali ta' Sandimmun, kienu ntużaw dożi inizjali fil-medda ta' 14-18 mg/kg/jum u sussegwentement ġew imnaqqsa għal doża ta' manteniment fil-medda ta' 6-10 mg/kg/jum.
English: Concerning the sub-sections on infections, renal toxicity and hepatotoxicity, monitoring ciclosporin levels in transplant patients, hypertension, blood lipids increased, live-attenuated vaccines and interactions, wordings were proposed by the MAH and intensively discussed and revisited as per CHMP requests.
Maltese: Fir-rigward tas-sottosezzjonijiet dwar infezzjonijiet, tossiċità tal-kliewi u epatotossiċità, monitoraġġ tal-livelli ta' ciclosporin f'pazjenti bi trapjanti, pressjoni għolja, żieda fil-lipidi fid-demm, vaċċini ħajjin attenwati u interazzjonijiet, il-kliem ġie propost mill-MAH u ġie diskuss u rivedut b'mod intensiv skont it-talbiet tas-CHMP.
English: The Psoriasis is an approved therapeutic indication in all EU countries.
Maltese: Il-Psorjasi hija indikazzjoni terapewtika approvata fil-pajjiżi kollha tal-UE.
English: This approach was acceptable to the CHMP and final wordings in sections 4.2 and 4.4.were agreed accordingly.
Maltese: Dan l-approċċ kien aċċettabbli għas-CHMP u l-kliem finali fis sezzjonijiet 4.2 u 4.4.kien maqbul kif xieraq.
English: This data, along with ciclosporin experience in other nontransplant diseases, helped to design the four pivotal placebocontrolled double-blind Sandimmun (SIM) trials in severe RA in the US and Canada.
Maltese: Din id-dejta, flimkien mal-esperjenza b'ciclosporin f'mard ieħor li ma jinvolvix trapjant, għenet biex jiġu ddisinjati l-erba' provi pivotali bi blindaġġ doppju, ikkontrollati bi plaċebo, ta' Sandimmun (SIM) f'RA severa fl-Istati Uniti u l-Kanada.
English: With regards to the paragraphs concerning Medical supervision, Lymphomas and other malignancies, Geriatrics, Hyperkalaemia, Hypomagnesemia and Hyperuricaemia, Special excipients, the MAH proposed the CSP wording as the harmonised SmPC text.
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Fir-rigward tal-paragrafi dwar Superviżjoni medika, Linfomi u tumuri malinni oħra, Ġerjatrija, Iperkalimja, Ipomagnesimja u Iperuriċemija, Eċċipjenti speċjali, il-MAH ippropona l-kliem tas-CSP
English: Further to this introduction paragraph on non-transplantation, the MAH proposed a posology for each of the non-transplantation indications (i.e. endogenous uveitis, nephrotic syndrome, rheumatoid arthritis, psoriasis, atopic dermatitis).
Maltese: Wara dan il-paragrafu ta' introduzzjoni dwar każijiet li ma jinvolvux trapjant, il-MAH ippropona pożoloġija għal kull indikazzjoni li ma tinvolvix trapjant (jiġifieri uveite endoġena, sindromu nefrotiku, artrite rewmatika, psorjasi, dermatite atopika).
English: The CHMP also raised questions regarding the risk of aggravation of the neurological manifestations of Behcet's disease by Ciclosporin.
Maltese: Is-CHMP qajjem ukoll tħassib dwar ir-riskju ta' aggravar tal-manifestazzjonijiet newroloġiċi tal marda ta' Behcet b'Ciclosporin.
English: The MAH proposed the following wording for this indication: “Sandimmun Neoral is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Maltese: Il-MAH ippropona l-kliem li ġej għal din l-indikazzjoni: “Sandimmun Neoral huwa indikat f'pazjenti b'dermatite atopika severa meta tkun meħtieġa terapija sistemika.”
English: The rationale given by the MAH for the proposed indication was based on the following data: the initial pilot study in active rheumatoid arthritis used a dose of 10 mg/kg/day, half the dose used in solid organ transplantation at that time.
Maltese: Ir-raġuni mogħtija mill-MAH għall-indikazzjoni proposta kienet ibbażata fuq id-dejta li ġejja: listudju pilota inizjali fl-artrite rewmatika attiva uża doża ta' 10 mg/kg/kuljum, nofs id-doża użata fi trapjant ta' organu solidu dak iż-żmien.
English: A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Maltese: Kliem rivedut ġie propost mill-MAH kif xieraq u approvat mis-CHMP.
English: All MS except Norway have the indication bone marrow transplantation and GVHD approved.
Maltese: L-SM kollha ħlief in-Norveġja għandhom l-indikazzjoni tat-trapjant tal-mudullun u tal-GVHD approvata.
English: Sandimmun Neoral is available as Sandimmun Neoral soft gelatin capsules (10 mg, 25 mg, 50 mg and 100 mg) and Sandimmun Neoral oral solution, 100 mg/ml.
Maltese: (10 mg, 25 mg, 50 mg u 100 mg) u Sandimmun Neoral soluzzjoni orali, 100 mg/ml.
English: Seven trials were conducted for the prevention of graft-versus host disease (GVHD), one trial for the treatment of acute GVHD.
Maltese: GVHD, prova waħda għall-kura ta' GVHD akut.
English: To ensure that the Core Safety Information of the updated CDSs remains in line with the agreed CSP information, newly incorporated safety information into the CDS was proposed by the MAH for consideration into the agreed CSP, hence for the harmonized Eu SmPC safety related sections.
Maltese: ADRs oħra mill-esperjenza ta' wara t-tqegħid fis-suq, il-MAH ippropona li t-test armonizzat talSmPC jiġi armonizzat mas-CSP miftiehem.
English: The review of the original Sandimmun Dossiers from major markets such as France, the U.S. and UK which contains the clinical results from a total of 15 global studies has been performed.
Maltese: Saret ir-reviżjoni tad-Dossiers oriġinali ta' Sandimmun minn swieq maġġuri bħal Franza, l-Istati Uniti u r-Renju Unit li tinkludi r-riżultati kliniċi minn total ta' 15-il studju globali.
English: In addition, the CHMP requested the MAH to provide a clear rationale for having slightly different description of pharmacodynamic section in Sandimmun (both oral and injection) vs Sandimmun Neoral versions of SmPCs.
Maltese: Barra minn hekk, is-CHMP talab lill-MAH jipprovdi raġuni ċara għaliex kellu deskrizzjoni kemxejn differenti tas-sezzjoni tal-farmakodinamika f'Sandimmun (kemm orali kif ukoll injezzjoni) kontra l verżjonijiet tal-SmPCs ta' Sandimmun Neoral.
English: In parallel of these 9 performed studies, 2 double-blind placebo controlled multicenter studies and 1 multicenter study comparing ciclosporin with cyclophosphamide in steroidresistant patients had to be stopped prematurely because of a lack of suitable patients consenting to receive placebo or a cytostatic agent.
Maltese: Flimkien ma' dawn id-9 studji li saru, 2 studji multiċentriċi bi blindaġġ doppju kkontrollati bi plaċebo u studju multiċentriku wieħed li qabblu ciclosporin ma' cyclophosphamide f'pazjenti reżistenti għall-isterojdi kellu jitwaqqaf qabel iż-żmien minħabba li ma kienx hemm biżżejjed pazjenti xierqa li kienu taw ilkunsens biex jirċievu plaċebo jew aġent ċitostatiku.
English: In addition, a clarification of the B/R of ciclosporin in prevention of graft rejection after nonmyloablative stem cell transplantation was also requested by the CHMP; the CHMP reviewed the MAH's position and considered unnecessary to specify myeloablative vs. non-myeloablative stem cell transplantation in the Ciclosporin indication.
Maltese: Ciclosporin ġie studjat b'mod estensiv f'diversi provi kliniċi fuq pazjenti bl-artrite rewmatika li għalihom terapija konvenzjonali mhijiex effettiva jew mhux adatta, kif ukoll f'ħafna studji ppubblikati li rrapportaw l użu ta' ciclosporin f'din l-indikazzjoni.
English: The CHMP is of the view that the indication should be limited to primary glomerulonephritis cases as specified above.
Maltese: Is-CHMP huwa tal-fehma li l-indikazzjoni għandha tiġi limitata għal każijiet ta' glomerulonefrite primarja kif speċifikat hawn fuq.
English: The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Maltese: Il-kliem tal-indikazzjoni propost mill-MAH għall-artrite rewmatika huwa approvat fi 13-il pajjiż talUE.
English: The MAH explained that shelf life periods were not harmonised and proposed to follow the safest approach to Sandimmun (to fix 36 months period) and the last reduced period for Sandimmun Neoral that is approved in EU countries via variation procedure.
Maltese: Il-MAH spjega li l-perjodi ta' kemm idum tajjeb il-prodott mediċinali ma kinux armonizzati u ppropona li jiġi segwit l-aktar approċċ sigur għal Sandimmun (biex jiġi ffissat għal perjodu ta' 36 xahar) u l-aħħar perjodu mnaqqas għal Sandimmun Neoral approvat fil-pajjiżi tal-UE
English: Lastly, based on the fact that ciclosporin is a potent active substance associated with serious safety concerns, the CHMP was of the opinion that the posology section should clearly state that Sandimmun/Sandimmun Neoral is a product to be handled by specialists within the respective therapeutic area; a general wording was agreed and included accordingly in section 4.2.
Maltese: Sandimmun/Sandimmun Neoral huwa prodott li jrid jiġi mmaniġġjat minn speċjalisti fil-qasam terapewtiku rispettiv; il-kliem ġenerali ġie maqbul u inkluż kif xieraq fis-sezzjoni 4.2.
English: Additional pharmacokinetics and pharmacodynamics studies, as well as non clinical trials were performed with Sandimmun Neoral medicinal product to support its registration.
Maltese: Saru studji farmakokinetiċi u farmakodinamiċi addizzjonali, kif ukoll provi mhux kliniċi bil-prodott mediċinali Sandimmun Neoral biex jappoġġjaw ir-reġistrazzjoni tiegħu.
English: Non-transplantation indications:
Maltese: Indikazzjonijiet li ma jinvolvux trapjant:
English: Pediatric data from controlled and uncontrolled studies were also provided.
Maltese: Kienet ipprovduta wkoll dejta pedjatrika minn studji kkontrollati u mhux ikkontrollati.
English: The CHMP agreed with the wording proposed by the MAH.
Maltese: Is-CHMP qabel mal-proposta tal-MAH.
English: With regards to the treatment of rejection, the main concerns reflected by the CHMP related to the switch from tacrolimus, treatment of humoral rejections with Cyclosporin and in case of chronic allograft injury, as this has been seen as chronic rejection.
Maltese: Fir-rigward tal-kura ta' rifjut, it-tħassib prinċipali rifless mis-CHMP kien relatat mal-qalba minn tacrolimus, il-kura ta' rifjuti umorali b'Cyclosporin u fil-każ ta' korriment kroniku tal-allograft, peress li dan tqies bħala rifjut kroniku.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Maltese: • il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tas-sommarju tal-karatteristiċi talprodott, it-tikkettar u l-fuljett ta' tagħrif
English: In October 2010, Sandimmun Neoral was included in the list of products for Summary of Product Characteristics (SmPC) harmonization, requested by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: F'Ottubru 2010, Sandimmun Neoral kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas
English: Section 6.4 - Special precautions for storage
Maltese: Sezzjoni 6.4 - Prekawzjonijiet speċjali għall-ħażna
English: The MAH discussed the need of a contraindication of statins for cyclosporin and the need of further contraindications for other medicinal products/herbals.
Maltese: kontraindikazzjoni tal-istatins għal cyclosporin u l-ħtieġa ta' kontraindikazzjonijiet ulterjuri għal prodotti mediċinali/erbali oħra.
English: Based on the higher Cmax and AUC values achieved with Sandimmun Neoral compared to Sandimmun, the resulting individualized doses of Sandimmun Neoral were on average lower compared to Sandimmun.
Maltese: Istati Membri, is-CDSs ta' Sandimmun u Sandimmun Neoral kif iġġustifikati mir-reviżjoni ta' studjistoriċi u referenzi għal-letteratura.
English: In that context, a thorough comparison of the Feb 2011 agreed CSP information and the safety sections of the newly released CDSs was performed by the MAH.
Maltese: Frar 2011 u s-sezzjonijiet dwar is-sigurtà tas-CDSs li kienu għadhom kif ġew rilaxxati.
English: Based on the above the CHMP considers the benefit/risk ratio of Sandimmun Neoral to be favourable and the harmonised PI to be approvable.
Maltese: Abbażi ta' dan ta' hawn fuq is-CHMP iqis li l-proporzjon tal-benefiċċju/riskju ta' Sandimmun Neoral huwa favorevoli u l-PI armonizzat jista' jiġi approvat.
English: The promising benefit was offset by the renal dysfunction and hypertension.
Maltese: Il-benefiċċju promettenti kien affettwat b'mod negattiv middisfunzjoni renali u pressjoni għolja.
English: Two types of studies, open and controlled masked, were carried out in order to evaluate the efficacy of ciclosporin in the treatment of severe sight-threatening intermediate and posterior uveitis.
Maltese: Saru żewġ tipi ta' studji, miftuħa u masked ikkontrollati, sabiex tiġi evalwata l-effikaċja ta' ciclosporin fil-kura ta' uveite severa intermedja u posterjuri ta' theddida għall-vista.
English: Switching from Sandimmun to Sandimmun Neoral
Maltese: Sandimmum u ismijiet assoċjati (ara Anness I).
English: The MAH dedicated the whole sub-section to a comparison between Sandimmun and Sandimmun Neoral.
Maltese: Il-MAH iddedika s-sottosezzjoni kollha għal paragun bejn Sandimmun u Sandimmun Neoral.
English: The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
Maltese: • Sindromu nefrotiku (NS) Il-kliem tal-indikazzjoni propost mill-MAH għall-indikazzjoni tas-sindromu nefrotiku huwa approvat f'16-il pajjiż tal-UE.
English: After review of the dataset, the proposed posology in the bone marrow transplantation indication as approved in 16 EU MS was acceptable to the CHMP.
Maltese: Wara reviżjoni tas-sett tad-dejta, il-pożoloġija proposta fl-indikazzjoni għal trapjant tal-mudullun kif approvata f'16-il SM tal-UE kienet aċċettabbli għas-CHMP.
English: The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oilbased formulation (Sandimmun), first registered in Switzerland in December 1982.
Maltese: Ir reġistrazzjoni ta' Sandimmun Neoral kienet ibbażata fuq dejta dwar l-effikaċja u s-sigurtà minn studji kliniċi li saru bil-formulazzjoni b'bażi ta' żejt (Sandimmun), irreġistrata l-ewwel darba fl-Isvizzera f'Diċembru 1982.
English: The MAH addressed the points raised by the CHMP and proposed a final wording for this section on which the CHMP agreed.
Maltese: Il-MAH indirizza l-punti mqajma mis-CHMP u ppropona kliem finali għal din is-sezzjoni li s-CHMP qabel dwaru.
English: The MAH acknowledged that food affects the absorption of ciclosporin both from the Sandimmun formulation and, to a lesser extent, from the Sandimmun Neoral formulation.
Maltese: Meta mqabbel ma' Sandimmun (formulazzjoni ta' ciclosporin b'bażi ta' żejt), Sandimmun Neoral
English: To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Maltese: Abbażi tal-aktar kliem approvat b'mod komuni fl-Istati Membri tal-UE u l-verżjoni reċenti tal-iskeda tad-dejta ewlenija (CDS) tal-kumpanija datata 13 ta' Frar 2012, il-MAH ippropona kliem li diġà huwa approvat fi 13-il SM tal-UE.
English: The MAH proposed the CSP wording as the harmonized SmPC text for all sections except the additional text regarding interactions with bosentan/ ambrisentan and anthracycline antibiotics.
Maltese: Il-MAH ippropona l-kliem tas-CSP bħala t-test armonizzat tal-SmPC għas-sezzjonijiet kollha ħlief għat-test addizzjonali dwar l-interazzjonijiet ma' bosentan/ ambrisentan u antibijotiċi antraċiklini.
English: More specifically, considering data on ADRs frequencies in clinical trials the CHMP requested the MAH to state the reasons to set different frequencies comparing to the ones that have been calculated and thus, proposals were made with regards to some ADRs such as hyperglycaemia, headache, migraine, abdominal discomfort and gingival hyperplasia.
Maltese: Anness I) Sandimmun Neoral huwa formulazzjoni ta' ciclosporin mikroemulsifikata. Ciclosporin huwa sustanza immunosoppressiva qawwija li tintuża fi trapjanti ta' organi solidi umani u tal-mudullun biex jiġi evitat rifjut tat-trapjant u f'Mard tal-GVHD. Ciclosporin jintuża wkoll f'varjetà ta' kundizzjonijiet magħrufa, jew li jistgħu jiġu meqjusa, li huma ta' oriġini awtoimmuni (uveite endoġena, sindromu nefrotiku, artrite rewmatika, psorjasi u dermatite atopika).
English: The efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies.The clinical results from these 9 clinical studies were analyzed using a pooling of data from all studies (controlled and uncontrolled).
Maltese: Ir-riżultati kliniċi minn dawn id-9 studji kliniċi kienu analizzati bl-użu ta' ġbir tad-dejta mill-istudji kollha (ikkontrollati u mhux ikkontrollati).
English: Finally the CHMP also requested the MAH to discuss whether the heading “bone marrow transplantation” shall be updated to “allogenous stem cell transplantation”, i.e. independent from the source (else than non-host) of the stem cells and blasts.
Maltese: Fl-aħħar nett is-CHMP talab ukoll lill-MAH jiddiskuti jekk it-titolu “trapjant tal-mudullun” għandux jiġi aġġornat għal “trapjant alloġeniku taċ-ċelloli staminali”, jiġifieri indipendenti mis-sors (minbarra dak mhux tal-ospitu) taċ-ċelloli staminali u l-blasts.
English: The wording proposed by the MAH is already approved in 24 countries and several other countries have very similar information.
Maltese: Il-kliem propost mill-MAH huwa diġà approvat f'24 pajjiż u bosta pajjiżi oħra għandhom informazzjoni simili ħafna.
English: Teva Pharmaceuticals Ireland, L-Irlanda
Maltese: Teva Pharmaceuticals Ireland, L-Irlanda Tel:
English: - The active substance is epoetin theta.
Maltese: - Is-sustanza attiva hi epoetin theta.
English: Thromboembolic events
Maltese: Avvenimenti tromboembolitiċi
English: 89079 Ulm Germany
Maltese: 89079 Ulm
English: Fertility No data are available.
Maltese: Fertilità Dejta mhux disponibbli.
English: End of 7 days period at room temperature: __/__/____
Maltese: Tmiem il-perjodu ta' sebat ijiem f'temperatura ambjentali: __/__/____
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
Maltese: episodji tromboembolitiċi (RR 1.67, 95 % CI: 1.35, 2.06, 35 studji u 6,769 pazjent) kienet osservata f'pazjenti kkurati b'eritropojetin rikombinanti uman.
English: Preclinical efficacy
Maltese: sensittività eċċessiva
English: See also section 2.
Maltese: Ara wkoll sezzjoni 2
English: ≥ 1/100 to < 1/10;
Maltese: ≥ 1/100 sa < 1/10;
English: ≥ 1/10,000 to < 1/1,000;
Maltese: ≥ 1/10,000 sa < 1/1,000;
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).
Maltese: 1.08 favur il-kontrolli (95 % CI: 0.99, 1.18; 42 studji u 8,167 pazjent).
English: ≥ 1/1,000 to < 1/100;
Maltese: ≥ 1/1,000 sa < 1/100;
English: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm
English: The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Maltese: Is-sigurtà ta' epotein theta ġiet evalwata abbażi tar-riżultati mill-istudji kliniċi li inkludew 972 pazjent.
English: Hydrochloric acid (6 M) (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (6 M) (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Epoetin theta is a protein produced by biotechnology.
Maltese: Epoetin theta huwa proteina magħmula b'teknoloġija ġenetika.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Maltese: proporzjon ta' periklu ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għall-pazjenti bil-kanċer li kienu qed jirċievu kimoterapija, il-proporzjon ta' periklu ta' sopravivenza totali kien ta' 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.
Maltese: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (għal aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm
English: Influenza-like illness*
Maltese: Sindrome ta' influwenza*
English: Tlf: +45 44 98 55 11
Maltese: Teva Denmark A/S Tlf: +45 44 98 55 11
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet oħrajn kontra l-anemija, kodiċi ATC:
English: It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Maltese: Għandha titħalla tilħaq temperatura komda (15°C - 25°C) għall-injezzjoni.
English: Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.
Maltese: Epoetin theta huwa identiku fis-sekwenza tal-aċidi aminiċi u simili fil-kompozizzjoni ta' karboidrati tiegħu (glikosilat) għall-eritropojetin endoġenu uman.