FrancophonIA/ELRC3.0 huggingface dataset:
English: The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Maltese: Il-linja tal-qtugħ għal macimorelin ma ġiex stabbilit fil-perjodu tranżitorju mill-pubertà tardiva għal maturazzjoni sħiħa ta' adult.
English: The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Maltese: 70 kg jeħtieġ 70 mL ta' sospensjoni ta' macimorelin.
English: • Drinking - up to 100 mL of still water is allowed each within 1 hour before as well as within 1 hour after macimorelin intake.
Maltese: • Xorb - sa 100 mL ta' ilma mingħajr gass huwa permess fi żmien siegħa qabel kif ukoll fi żmien siegħa wara t-teħid ta' macimorelin.
English: What Macimorelin Aeterna Zentaris looks like and contents of the pack
Maltese: Kif jidher Macimorelin Aeterna Zentaris u l-kontenut tal-pakkett
English: You will have three blood samples taken to measure growth hormone, one sample each at 45, 60 and 90 minutes after taking the test dose.
Maltese: Se jittieħdu tliet kampjuni tad-demm għall-kejl tal-ormoni li jinkoraġġixxu t-tkabbir, kampjun wieħed kull 45, 60 u 90 minuta wara li ttieħed id-doża tat-test.
English: Macimorelin should be used with caution in patients with proarrhythmic condition (e.g., history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
Maltese: Lużu konkomitant ma' prodotti mediċinali li huma magħrufa li jikkawżaw torsades de pointes għandu jiġi evitat (ara wkoll is-sezzjoni 4.5). Macimorelin għandu jintuża b'kawtela f'pazjenti b'kundizzjoni proarrittmika (eż. storja ta' infart mijokardijaku, kollass kardijaku jew intervall tal-QTc tal-ECG imtawwal, kif definit bħala QTc > 500 ms).
English: EXP
Maltese: Bard
English: Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL.
Maltese: Nisa li jista' jkollhom it-tfal għandhom jużaw metodi kontraċettivi adegwati meta jingħata macimorelin.
English: Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes.
Maltese: Aprotinin, li huwa polypeptide li jinstab b'mod naturali, huwa inibitur tal-enzimi proteolitiċi.
English: Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA).
Maltese: Is-CHMP ħareġ opinjonijiet u konklużjonijiet separati għat-tliet antifibrinolitiċi (aprotinin, EACA u TXA).
English: Aminocaproic acid is a lysine analogue authorised for several indications since 1963.
Maltese: Aminocaproic acid huwa analogu ta' lysine awtorizzat għal diversi indikazzjonijiet sa mill-1963.
English: This document presents the conclusions on EACA.
Maltese: Dan id-dokument jippreżenta l-konklużjonijiet dwar EACA.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, għal aprotinin, aminocaproic acid u tranexamic acid (ara Anness I).
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Maltese: L-analogu ta' lysines epsilon aminocaproic acid (EACA, imsejjaħ ukoll aminocaproic acid) u tranexamic acid (TXA) jinibixxu b'mod iktar speċifiku l-konverżjoni ta' plasminogen f'plasmin.
English: Aminocaproic acid has also been associated with hypotension, nasal and conjunctival congestion, gastrointestinal disturbances (diarrhoea, nausea, vomiting, abdominal pain), dizziness, headache, tinnitus and ejaculation disorders; blood disorders (agranulocytosis, coagulation disorders), muscular damage, convulsions, anaphylactic reactions, renal impairment, and thrombotic complications.
Maltese: Aminocaproic acid ġie assoċjat ukoll ma' pressjoni baxxa, konġestjoni nażali u konġuntivali, disturbi gastro-intestinali (dijarea, dardir, rimettar, uġigħ addominali), sturdament, uġigħ ta' ras, tinnitus u disturbi fl-eġakulazzjoni; disturbi fid-demm (agranuloċitosi, disturbi filkoagulazzjoni), ħsara muskolari, konvulżjonijiet, reazzjonijiet anafilattiċi, indeboliment renali, u komplikazzjonijiet trombotiċi.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Maltese: L-opinjoni tal-Kumitat ġiet iffurmata permezz ta' diversi sorsi ta' dejta, inkluż dejta disponibbli minn studji kliniċi, dokumentazzjoni ppubblikata, rapporti spontanji u dejta oħra sottomessa middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ta' prodotti mediċinali li fihom aprotinin, EACA jew TXA.
English: Data available from randomised clinical trials and observational studies, including meta-analysis were considered.
Maltese: Ġiet ikkunsidrata d-dejta disponibbli minn provi kliniċi randomizzati u minn studji ta' osservazzjoni, inkluż meta-analiżi.
English: In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications.
Maltese: F'Marzu 2010, il-Ġermanja tat bidu għal riferiment skont l-Artikolu 31 sabiex jiġu evalwati lbenefiċċji u r-riskji tal-mediċini antifibrinolitiċi aprotinin, EACA u TXA fl-indikazzjonijiet approvati kollha tagħhom.
English: Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement) - gastroenterology - odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulant therapy)
Maltese: Emorraġiji wara l-kirurġija fl-: - uroloġija (kirurġija tal-bużżieqa tal-awrina u tal-prostata) - ġinekoloġija (kirurġija ċervikali), f'pazjenti fejn tranexamic acid ma jkunx disponibbli jew mhux ittollerat - ostetriċja (emorraġiji wara t-twelid u wara korriment) wara korrezzjoni tad-difett ta' koagulazzjoni - kirurġija tal-qalb (bit-tqegħid ta' bypass jew mingħajru) - ġastroenteroloġija - odonto-stomatoloġija (estrazzjonijiet dentali f'pazjenti emofiljaċi, pazjenti li qegħdin jieħdu terapija antikoagulanti)
English: The results of the BART trial did not have a negative impact on the benefit risk profile of EACA.
Maltese: Ir-riżultati tal-prova BART ma kellhomx impatt negattiv fuq il-profil tal-benefiċċju-riskju ta' EACA.
English: • The Committee considered the available scientific data, including evidence from new studies, on the efficacy of EACA.
Maltese: • Il-Kumitat ikkunsidra d-dejta xjentifika disponibbli, inkluż evidenza minn studji ġodda, dwar leffikaċja ta' EACA.
English: Aminocaproic acid is indicated for use in patients of all ages in haemorrhage caused by local or general fibrinolysis, including in
Maltese: Aminocaproic acid huwa indikat għall-użu f'pazjenti ta' kull età f'emorraġiji kkawżati minn fibrinoliżi ġenerali jew lokali, inkluż f'
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Maltese: Ir-riżultati preliminari ta' prova klinika kkontrollata randomizzata, l-istudju dwar il-‘Konservazzjoni tad-demm permezz tal-antifibrinolitiċi: prova randomizzata f'popolazzjoni ta' kirurġija tal-qalb' (BART), urew li minkejja li l-użu ta' aprotinin kien assoċjat ma' fsadiet inqas serji minn dawk li jirriżultaw millmediċini ta' tqabbil, ġiet osservata żieda fir-rata ta' mortalità fuq perjodu ta' 30 jum minħabba kwalunkwe kawża fost il-pazjenti li kienu qegħdin jirċievu aprotinin meta mqabbel ma' pazjenti li kienu qegħdin jieħdu mediċini oħra.
English: Leukopenia, thrombocytopenia, BUN (blood urea nitrogen) increased and renal failure are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Maltese: Il-lewkopenja, it-tromboċitopenija, iż-żieda fin-nitroġenu urejku fid-demm (BUN blood urea nitrogen) u l-insuffiċjenza renali huma avvenimenti avversi li jistgħu jkunu serji u li ġew irrapportati, iżda dawn ir-riskji ma ġewx ikkunsidrati fl-informazzjoni attwali awtorizzata dwar ilprodott.
English: The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq ta' EACA u TXA ma ġewx affettwati mir-reviżjoni inizjali tal-2007.
English: The safety profile of EACA has evolved since its authorisation, and safety data has accumulated over the years.
Maltese: Il-profil tas-sigurtà ta' EACA evolva mill-awtorizzazzjoni tiegħu, u d-dejta ta' sigurtà akkumulata matul is-snin.
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of EACA.
Maltese: Is-CHMP ikkunsidra wkoll il-profil ta' reazzjonijiet avversi, inkluż avvenimenti avversi ġodda (xi wħud minnhom serji) assoċjati mal-użu ta' EACA.
English: patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement)
Maltese: pazjenti ta' kull età f'emorraġija kkawżata minn fibrinoliżi lokali jew ġenerali, inkluż f'emorraġiji wara l-kirurġija fil-: - uroloġija (kirurġija tal-bużżieqa tal-awrina u tal-prostata) - ġinekoloġija (kirurġija ċervikali), f'pazjenti fejn tranexamic acid ma jkunx disponibbli jew mhux ittollerat - ostetriċja (emorraġiji wara t-twelid u wara korriment) wara korrezzjoni tad-difett ta' koagulazzjoni - kirurġija tal-qalb (bit-tqegħid ta' bypass jew mingħajru) - ġastroenteroloġija - odonto-stomatoloġija (estrazzjonijiet dentali f'pazjenti emofiljaċi, pazjenti li qegħdin jieħdu terapija antikoagulanti)
English: EACA had not previously been associated with an increased risk of mortality and this has remained unchanged postpublication of the BART study.
Maltese: EACA ma kienx ġie assoċjat qabel ma' riskju akbar ta' mortalità u dan baqa' ma nbidilx wara l-pubblikazzjoni tal-istudju BART.
English: Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss.
Maltese: Antifibrinolitiċi (eż. aprotinin, aminocaproic acid u tranexamic acid), huma klassi ta' aġenti emostatiċi li jintużaw biex jiġi evitat li jintilef ammont eċċessiv ta' demm.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aminocaproic acid containing medicinal products (see Annex I)
Maltese: Prodotti mediċinali li fihom aminocaproic acid (ara Anness I).
English: It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein.
Maltese: Għandu azzjoni wiesgħa fuq l-enzimi proteolitiċi bħal plasmin, trypsin u kallikrein.
English: A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review.
Maltese: F'Ottubru 2011 ġiet organizzata laqgħa tal-grupp ta' konsulenza xjentifika (SAG) tas-CHMP u l-fehmiet li tqajmu fiha ġew ikkunsidrati mis-CHMP fil-qafas ta' din ir-reviżjoni.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for aminocaproic acid containing medicinal products presented by the EMA
Maltese: Raġunijiet għall-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom aminocaproic acid elenkati fl-Anness I
English: • The Committee considered all data provided by the MAHs in writing, including data available from literature reviews.
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha pprovduta bil-miktub mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż dejta disponibbli mir-reviżjonijiet tad-dokumentazzjoni.
English: 20 November 2008
Maltese: 20 ta' Novembru 2008
English: Ref. EMEA/124262/2009
Maltese: EMEA/122010/2009
English: Opinion date:
Maltese: Data tal-Opinjoni:
English: Prof. Ingemar Persson
Maltese: Il-Profs Ingemar Persson
English: Dr. Harald Enzmann
Maltese: It-tabib Harald Enzmann
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: Artikolu 29 tad-Direttiva 2001/83/KE kif emendat, referenza abbażi ta' riskju serju potenzjali għas-saħħa pubblika
English: Implanon subdermal implant etonogestrel 68 mg
Maltese: Mistoqsija u tweġiba dwar ir-referenza għall-impjant taħt il-ġilda Implanon etonogestrel 68 mg
English: What is Implanon?
Maltese: X'inhu Implanon?
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont referenza tal-‘Artikolu 29'1.
English: The active substance in Implanon, etonogestrel, is a synthetic female hormone resembling progesterone.
Maltese: Is-sustanza attiva f'Implanon, etonogestrel, hija ormon femminili sintetiku li jixbaħ lill-proġesteron.
English: London, 09 February 2009 Doc.
Maltese: Londra, 09 ta' Frar 2009 Dok ta' Ref.
English: N.V. Organon submitted Implanon for a second renewal of the marketing authorisation through mutual recognition on the basis of the initial authorisation granted by the Netherlands on 25 August 1998.
Maltese: N.V. Organon issottomettiet Implanon għat-tieni tiġdid tal-awtorizzazzjoni għat-tqegħid fis-suq permezz ta' rikonoxximent reċiproku fuq il-bażi tal-ewwel awtorizzazzjoni mogħtija mill-Olanda fil25 ta' Awwissu 1998.
English: Why was Implanon reviewed?
Maltese: Għalfejn ġie rivedut Implanon?
English: On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.
Maltese: Fis-6 ta' Ottubru 2008, l-aġenzija regolatorja Olandiża rreferiet il-kwistjoni lis-CHMP.
English: Implanon is a female contraceptive.
Maltese: Implanon huwa kontraċettiv għan-nisa.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Implanon.
English: Implanon can protect for up to three years; at the end of this period the implant must be removed.
Maltese: Implanon jista' jipproteġi sa tliet snin; wara dan il-perijodu l-impjant għandu jitneħħa.
English: The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised.
Maltese: Il-kumpanija riedet li t-tiġdid tal-awtorizzazzjoni jkun rikonoxxut fl-Istati Membri kollha tal-UE, kif ukoll fin-Norveġja u fl-Iżlanda fejn il-prodott huwa diġà awtorizzat.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Implanon outweigh its risks, and therefore the renewal of the marketing authorisation for Implanon should be granted in all concerned member states.
Maltese: IlKumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li lbenefiċċji ta' Implanon huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq li ngħatat fl-Olanda tista' tiġi rikonoxxuta fi Stati Membri oħra tal-Unjoni Ewropea.
English: The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Maltese: Is-CHMP aċċetta wkoll il-bidliet fl-informazzjoni tal-prodott għall-mediċina kif miftiehem mill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati.
English: Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
Maltese: EU/1/13/873/001 Xofigo 1100 kBq/mL Soluzzjoni għall-injezzjoni
English: Vial (glass)
Maltese: Kunjett (ħġieġ)
English: 1 vial
Maltese: Daqs talpakkett
English: Two-sided 99.24% CI
Maltese: Miż-żewġ naħat 99.24 % CI
English: Fanconi syndrome
Maltese: Sindrome ta' Fanconi
English: 9/L but is ≥0.7 x10
Maltese: 9/L iżda hu ≥0.7 x10
English: Proteinuria* Renal failure* Fanconi syndrome*
Maltese: Proteinurija* Insuffiċjenza renali* Sindrome ta' Fanconi*
English: 593, Sant Andreu de la Barca, Barcelona, 08740, Spain
Maltese: Nacional II, Km. 593, Sant Andreu de la Barca, Barcelona, 08740, Spain
English: България/ Česká republika/ Eesti/ Ελλάδα/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija/ Slovenská republika Almirall, S.A., Teл./ Tel/ Τηλ: +34 93 291 30 00
Maltese: Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija/ Slovenská republika Almirall, S.A., Teл./ Tel/ Τηλ: +34 93 291 30 00
English: Acute lymphatic leukaemia* Irreversible pancytopenia*
Maltese: Lewkimja linfatika akuta* Panċitopenija irreversibbli*
English: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Maltese: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 u 400 pillola gastroreżistenti f'folji talPVC/PVDC-aluminju.
English: Common Common Common Rare
Maltese: Komuni Komuni Komuni Rari
English: Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Maltese: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 u 400 pillola gastroreżistenti.
English: 9/L, lymphopenia below 1.0x10
Maltese: 9/L, linfopenija taħt 1.0x10
English: The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg).
Maltese: Iddoża massima permessa f'ġurnata hija ta' 720 mg (3 x 2 pilloli Skilarence 120 mg).
English: The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) and lymphopenia (10.0%).
Maltese: L-aktar reazzjonijiet avversi komuni osservati bi Skilarence fl-istudju kliniku tal-Fażi III (1102) f'pazjenti bi psorijażi kienu avvenimenti gastrointestinali (62.7 %), vampati (20.8 %) u linfopenija (10.0 %).
English: One-sided 97.5% repeated CI (lower limit)
Maltese: Minn naħa waħda 97.5 % CI repetut (limitu aktar baxx)
English: Progressive multifocal leukoencephalopathy*
Maltese: Lewkoċefalopatija multifokali progressiva*
English: - Severe gastrointestinal disorders.
Maltese: − Disturbi gastro-intestinali severi.
English: Skilarence 30 mg and Skilarence 120 mg Core:
Maltese: Skilarence 30 mg u Skilarence 120 mg Qalba:
English: Industrias Farmaceuticas Almirall, S.A.
Maltese: Industrias Farmacéuticas Almirall, S.A. Ctr.
English: Skilarence contains sodium
Maltese: Skilarence fih sodium
English: PML is probably caused by a combination of factors.
Maltese: Probabbli, PML hija kkawżata minn kombinazzjoni ta' fatturi.
English: Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8).
Maltese: Infezzjonijiet opportunistiċi/lewkoenċefalopatija multifokali progressiva (PML) Ġew irrappurtati każijiet ta' infezzjonijiet opportunistiċi, b'mod partikolari ta' lewkoenċefalopatija multifokali progressiva (PML) bi prodotti oħrajn li fihom dimethyl fumarate (ara sezzjoni 4.8).
English: 42 gastro-resistant tablets 70 gastro-resistant tablets 210 gastro-resistant tablets
Maltese: 42 pillola gastroreżistenti 70 pillola gastroreżistenti 210 pillola gastroreżistenti
English: Most patients (91%) were <65 years of age.
Maltese: Ħafna millpazjenti (91%) kellhom <65 sena.
English: Very common Very common Common Common Very rare Very rare
Maltese: Komuni ħafna Komuni ħafna Komuni Komuni Rari ħafna Rari ħafna
English: The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
Maltese: Luniċi reazzjonijiet avversi li wasslu għal waqfien tal-kura f'>5% tal-pazjenti kienu reazzjonijiet gastrointestinali.
English: 40 gastro-resistant tablets 70 gastro-resistant tablets 90 gastro-resistant tablets 100 gastro-resistant tablets 120 gastro-resistant tablets 180 gastro-resistant tablets 200 gastro-resistant tablets 240 gastro-resistant tablets 300 gastro-resistant tablets 360 gastro-resistant tablets 400 gastro-resistant tablets
Maltese: 40 pillola gastroreżistenti 70 pillola gastroreżistenti 90 pillola gastroreżistenti 100 pillola gastroreżistenti 120 pillola gastroreżistenti 180 pillola gastroreżistenti 200 pillola gastroreżistenti 240 pillola gastroreżistenti 300 pillola gastroreżistenti 360 pillola gastroreżistenti 400 pillola gastroreżistenti
English: Superiority testing vs placebo PASI 75, n (%) p-value a a
Maltese: Ittestjar tas-superjorità vs plaċebo PASI 75, n (%) valur-p
English: No specific antidote is known.
Maltese: Ma huwa magħruf ebda antidotu speċifiku.
English: Number of tablets
Maltese: In-numru ta' pilloli
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
Maltese: PML hija infezzjoni opportunistika kkawżata mill-virus ta' John-Cunningham (John-Cunningham virus, JCV) li tista' tkun fatali jew tikkkawża diżabilitajiet severi.
English: This interaction with glutathione leads to the inhibition of translocation into the nucleus and the transcriptional activity of the nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB).
Maltese: L-interazzjoni mal-glutatjon twassal għall-inibizzjoni ta'trażlokazzjoni fin-nukleu u l-attività traskrizzjonali tal-fattur nukleari kappa-light-chain-enhancer taċ-ċelloli-B attivati (NF-κB).
English: E-08740 Sant Andreu de la Barca, Barcelona Spain
Maltese: Sant Andreu de la Barca, Barcelona Spanja
English: EU/1/17/1201/002 40 tablets EU/1/17/1201/003 70 tablets EU/1/17/1201/004 90 tablets EU/1/17/1201/005 100 tablets EU/1/17/1201/006 120 tablets EU/1/17/1201/007 180 tablets EU/1/17/1201/008 200 tablets EU/1/17/1201/009 240 tablets EU/1/17/1201/012 300 tablets EU/1/17/1201/010 360 tablets EU/1/17/1201/011 400 tablets
Maltese: EU/1/17/1201/002 40 pillola EU/1/17/1201/003 70 pillola EU/1/17/1201/004 90 pillola EU/1/17/1201/005 100 pillola EU/1/17/1201/006 120 pillola EU/1/17/1201/007 180 pillola EU/1/17/1201/008 200 pillola EU/1/17/1201/009 240 pillola EU/1/17/1201/012 300 pillola EU/1/17/1201/010 360 pillola EU/1/17/1201/011 400 pillola
English: Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours.
Maltese: It-teħid ta' Skilarence mal-ikel ittardja t-tmax tal-monomethyl fumarate minn 3.5 għal 9.0 sigħat.
English: Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Maltese: 42, 70 u 210 pillola gastroreżistenti f'folji tal-PVC/PVDC-aluminju.