FrancophonIA/ELRC3.0 huggingface dataset:
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Maltese: • f' kombinazzjoni mal-metformina f' pazjenti li ma jkunux ikkontrollati b' mod sodisfaċenti bilmetformina weħidha, jew bis-sulfonilurea (tip ieħor ta' mediċina kontra d-dijabete) meta lmetformina ma tkunx adatta f' pazjenti li ma jkunux ikkontrollati b' mod sodisfaċenti bissulfonilurea weħidha;
English: The Committee recommended that Pioglitazone Accord be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pioglitazone Accord ikun approvat għall-użu fl-UE.
English: How is Pioglitazone Accord used?
Maltese: Kif jintuża Pioglitazone Accord?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete tat-tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju fid-demm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b' mod effikaċi.
English: Pioglitazone Accord is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Pioglitazone Accord jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena ' l fuq), b' mod partikulari f' dawk li jkollhom piż eċċessiv.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable.
Maltese: • waħdu f' pazjenti li għalihom il-metformina (mediċina oħra kontra d-dijabete) mhijiex adatta;
English: • together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
Maltese: • flimkien ma' kemm il-metformina kif ukoll is-sulfonilurea fil-pazjenti li mhumiex ikkontrollati b' mod sodisfaċenti minkejja kura b' żewġ mediċini mill-ħalq;
English: Why is Pioglitazone Accord approved?
Maltese: Għaliex ġie approvat Pioglitazone Accord?
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Maltese: • flimkien mal-insulina f' pazjenti li ma jkunux ikkontrollati b' mod sodisfaċenti bl-insulina weħidha u li ma jistgħux jieħdu l-metformina.
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Actos, il-benefiċċji huma akbar mir-riskju identifikat.
English: How does Pioglitazone Accord work?
Maltese: Kif jaħdem Pioglitazone Accord?
English: Further information on Opsumit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Opsumit tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Opsumit contains the active substance macitentan.
Maltese: Opsumit fih is-sustanza attiva macitentan.
English: Other information about Opsumit
Maltese: Informazzjoni oħra dwar Opsumit
English: Opsumit is used for adults whose PAH is classified as WHO functional class II to class III.
Maltese: Opsumit jintuża għal adulti li l-PAH tagħhom hija kklassifikata bħala klassi funzjonali tal-WHO II sa klassi III.
English: Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Aktar informazzjoni fuq id-denominazzjoni orfni tista' tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What are the risks associated with Opsumit?
Maltese: X'inhuma r-riskji assoċjati ma' Opsumit?
English: Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH).
Maltese: Opsumit huwa mediċina li tintuża għall-kura fit-tul ta' ipertensjoni arterjali pulmonari (PAH).
English: Opsumit received a marketing authorisation valid throughout the EU on 20 December 2013.
Maltese: Opsumit irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fl-20 ta' Diċembru 2013.
English: PAH is ‘rare', and Opsumit was designated an ‘orphan medicine' (a medicine used in rare diseases) for PAH on 27 September 2011.
Maltese: PAH hija ‘rari', u Opsumit ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għal PAH fis-27 ta' Settembru 2011.
English: Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.
Maltese: Madwar 37 % tal-pazjenti li kienu qegħdin jieħdu plaċebo kellhom aggravar tas-sintomi tagħhom tal-PAH meta mqabbel ma' 24 % ta' dawk li ħadu Opsumit 10 mg.
English: In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms.
Maltese: Fi studju ewlieni li involva 742 pazjent, Opsumit intwera li jnaqqas ir-riskju ta' mard relatat mal-PAH, partikolarment l-aggravar tas-sintomi tal-PAH.
English: Most side effects are mild to moderate in severity.
Maltese: Ħafna mill-effetti sekondarji huma minn ħfief sa moderati fis-severità.
English: The most common side effects with Opsumit (which may affect more than 1 in 10 people) include nasopharyngitis (inflammation of the nose and throat), anaemia (low red blood cell counts) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Opsumit (li jistgħu jaffettwaw aktar minn 1 minn kull 10) jinkludu nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), anemija (għadd baxx ta' ċelloli ħomor taddemm) u uġigħ ta' ras.
English: As for all medicines, data on the use of Opsumit are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Opsumit hija ssorveljata kontinwament.
English: The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Maltese: Is-sustanza attiva f'Opsumit, macitentan, taħdem billi timblokka r-riċetturi tal-endotelina.
English: The medicine is available as 10 mg tablets and taken at a dose of one tablet every day.
Maltese: Il-mediċina tiġi bħala pilloli ta' 10 mg u tittieħed f'doża ta' pillola waħda kuljum.
English: Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable.
Maltese: Opsumit intwera li huwa effettiv biex inaqqas il-mard jew mewt ikkaġunat mill-PAH u l-effetti sekondarji rrappurtati huma simili għal dawk irrappurtati b'mediċini oħra tal-klassi tegħu u jitqiesu bħala li jistgħu jiġu mmaniġġjati.
English: The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity.
Maltese: Il-klassi tirrifletti s-serjetà tal-marda: pazjenti b'PAH ta' klassi II għandhom ftit limitazzjoni ta' attività fiżika u dawk b'marda ta' klassi
English: How is Opsumit used?
Maltese: Kif jaħdem Opsumit?
English: Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Maltese: Minħabba li tkun meħtieġa aktar pressjoni biex tisforza d-demm jgħaddi mill-arterja li tkun djieqet, dan iwassal għal pressjoni tad-demm għolja filpulmun.
English: The company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit.
Maltese: Il-kumpanija li tqiegħed Opsumit fis-suq ser tibgħat materjal edukattiv lill-pazjenti u lill-professjonisti fil-qasam tal-kura tas-saħħa b'informazzjoni dwar il-prekawzjonijiet li għandhom jittieħdu meta jintuża Opsumit.
English: What measures are being taken to ensure the safe and effective use of Opsumit?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Opsumit?
English: • attenuated Chlamydophila felis (905 strain),
Maltese: • Chlamydophila felis attenwata (razza 905),
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Maltese: Tilqima kontra r-rinotrakeite virali felina, il-klamidjożi felina, il-panlewkopenja felina (ħajja attenwata) u l-kaliċivirożi felina (inattivata)
English: Other information about Purevax RCPCh:
Maltese: Informazzjoni oħra dwar Purevax RCPCh:
English: The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Maltese: L-effikaċja ta' Purevax RCPCh ġiet studjata f'diversi provi f'kundizzjonijiet tal-laboratorju fejn qtates ġew imlaqqma u infettati bil-virus tal-erpete, bil-kaliċivirus, b'C. felis jew bil-parvovirus.
English: Purevax RCPCh is a veterinary vaccine that contains:
Maltese: Purevax RCPCh huwa tilqima veterinarja li fiha:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Purevax RCPCh fit-23 ta' Frar 2005.
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Maltese: • klamidjożi felina (marda li tixbah lill-influwenza kkawżata mill-batterju C. felis),
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Purevax RCPCh huma akbar mir-riskji għall-indikazzjonijiet approvati u rrakkomanda li Purevax RCPCh jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Maltese: Purevax RCPCh jintuża għat-tilqim ta' qtates mill-età ta' 8 ġimgħat kontra l-mard li ġej:
English: What is Purevax RCPCh?
Maltese: X'inhu Purevax RCPCh?
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Maltese: Fl-istudju li eżamina t-tilqim booster, il-livelli tal-anitkorpi kontra l-virus tal-erpete tar-rinotrakeite, l-infezzjoni tal-kaliċivirus, u l-viruses tal-panlewkopenja felina u C. felis baqgħu stabbli f'livell għoli jew żdiedu bi ftit.
English: For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Purevax RCPCh, ara l-fuljett ta' tagħrif.
English: Why has Purevax RCPCh been approved?
Maltese: Għaliex ġie approvat Purevax RCPCh?
English: In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
Maltese: F'kundizzjonijiet tal-laboratorju Purevax RCPCh intwera li jipprovdi protezzjoni kontra l-mard elenkat hawn fuq.
English: Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Maltese: Purevax RCPCh fih ammonti żgħar ta' viruses u ta' batterji mdgħajfa jew maqtula li jikkawżaw ir-rinotrakeite, il-kaliċivirożi, il-klamidjożi u l-panlewkopenja tal-qtates.
English: What is the risk associated with Purevax RCPCh?
Maltese: X'inhuma r-riskji assoċjati ma' Purevax RCPCh?
English: How has Purevax RCPCh been studied?
Maltese: Kif ġie studjat Purevax RCPCh?
English: Replagal agalsidase alfa
Maltese: Replagal agalsidażi alfa
English: The full EPAR for Replagal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A further study was carried out in 15 female patients.
Maltese: Studju ieħor sar fuq 15-il pazjenta femminili.
English: Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Maltese: Replagal jingħata darba kull ġimagħtejn bħala infużjoni ta' 0.2 mg/kg tal-piż tal-ġisem fuq medda ta' 40 minuta.
English: Replagal is an enzyme replacement therapy.
Maltese: Replagal hu terapija enzimatika sostituttiva.
English: Replagal is medicine that contains the active substance agalsidase alfa.
Maltese: Replagal huwa mediċina li fiha s-sustanza attiva agalsidażi alfa.
English: The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Maltese: Is-sustanza attiva f'Replagal, l-agalsidażi alfa, hija kopja tal-enzima umana, prodotta b'metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': dan isir minn ċelloli li jkunu rċevew ġene (DNA), li jagħmilha kapaċi tipproduċi l-enzima.
English: Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Maltese: Replagal naqqas il-massa tal-ventrikolu tax-xellug b' medja ta' 11.5 g filwaqt li l-pazjenti li kienu qed jingħataw plaċebo kellhom żieda fil-massa tal-ventrikolu tax-xellug ta' 21.8 g.
English: This is a summary of the European public assessment report (EPAR) for Replagal.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Replagal.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Maltese: Din l-enżima normalment tkisser is-sustanza xaħmija msejħa globotrijaosilċeramide (Gb3 jew GL-3).
English: These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Maltese: Dawn jinkludu tertir, uġigħ ta' ras, nawżja, piressija (deni), uġigħ u skumdità, ħmura u għeja, u rarament ikunu gravi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Replagal valida fl-Unjoni Ewropea kollha fit-3 ta' Awwissu 2001.
English: Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Maltese: Replagal kien oriġinarjament awtorizzat taħt “ċirkostanzi ta' eċċezzjoni”, għaliex minħabba li l-marda hija rari, kien hemm informazzjoni limitata disponibbli fi żmien l-approvazzjoni.
English: Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Maltese: Replagal ġie evalwat ukoll fi studji oħra li involvew 38 tifel u tifla minn 7 snin 'il fuq.
English: Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Maltese: Replagal tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew total ta' 40 pazjent maskili.
English: It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Maltese: Jiġi f'konċentrat li jingħamel f'soluzzjoni għal infużjoni (dripp) fil-vina.
English: How has Replagal been studied?
Maltese: Kif ġie studjat Replagal?
English: The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Maltese: L-effetti sekondarji l-aktar komuni b'Replagal (li dehru f'aktar minn pazjent 1 minn 10) huma reazzjonijiet assoċjati mal-infużjoni.
English: The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
Maltese: Is-CHMP ddeċieda li f'pazjenti morda bil-marda ta' Fabry, il-kura b'Replagal tista' tipprovdi benefiċċji kliniċi fit-tul.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Maltese: Peress li l-kumpanija pprovdiet l-informazzjoni addizjonali mitluba, iċ-‘ċirkostanzi ta' eċċezzjoni' tneħħew fl-20 ta' Lulju
English: After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Maltese: Wara 6 xhur ta' kura, Replagal naqqas sinifikattivament l-uġigħ fil-pazjenti meta mqabbel mal-plaċebo.
English: The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Maltese: L-ewwel studju kejjel l-effetti ta' Replagal fuq l-uġigħ filwaqt li t-tieni studju kejjel l-effett tiegħu fuq ilmassa tal-ventrikolu tax-xellug (muskolu tal-qalb), miżura tal-ammont tal-Gb3 fiċ-ċelloli tal-qalb.
English: What is Replagal?
Maltese: X'inhu Replagal?
English: What is the risk associated with Replagal?
Maltese: Għal xiex jintuża Replagal?
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Maltese: Il-persuni li jbatu minn din il-marda jista' jkollhom firxa sħiħa ta' sinjali u sintomi, li jinkludu kundizzjonijiet gravi bħal ħsara fil-kliewi, problemi fil-qalb u attakki ta' puplesija.
English: Content (concentrati on)
Maltese: Kontenut (konċentraz zjoni)
English: Concerns were raised on the proposed indications by an objecting member state, Germany.
Maltese: Tqajjem tħassib dwar l-indikazzjonijiet proposti minn Stat Membru li oġġezzjona, il-Ġermanja.
English: The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Maltese: Is-CHMP innota wkoll li l-bleomiċina għadha tintuża u msemmija wkoll fil-linji gwida terapewtiċi attwalment fis-seħħ fl-Ewropa u fl-Amerika ta' Fuq, bħalma huma SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), CCO (Cancer Care Ontario) Formulary, reviżjoni tal-2006/2007, u lGuidelines on penile cancer (Marzu 2004) tal-Assoċjazzjoni Ewropea tal-Uroloġija.
English: The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
Maltese: L-Applikazzjoni għal Bleomycin Pharmachemie ġiet sottomessa bħala applikazzjoni ġenerika bbażata fuq lawtorizzazzjoni għat-tqegħid fis-suq mogħtija għall-prodott ta' referenza fl-Olanda fit-18 ta' Novembru 1997.
English: In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio (RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Maltese: Barra ddokumentazzjoni diġà pprovduta waqt il-proċedura deċentralizzata, li tappoġġja rwol modest iżda ċert għallbleomiċina fit-trattament ta' SCCHN, numru ta' rapporti reċenti jappoġġjaw ir-rwol tal-bleomiċina flimkien ma' moieties kemjoterapewtiċi oħrajn, li jidentifikaw kemm proporzjon ta' rkupru (RR) ta' 34% fittrattament tat-tieni linja kif ukoll titjib fil-kontroll lokoreġjonali u sopravivenza f'pazjenti b'HNC avvanzat permezz ta' trattament konkomittanti radju- u kemjoterapewtiku postoperatorju b'mitomiċina Ċ u bleomiċina.
English: Bleomycin belongs to the cytostatic antibiotics: it is a mixture of structurally related, alkaline, water soluble, glycopeptide antibiotics with a cytostatic effect.
Maltese: Il-bloemiċina (bleomycin) tappartieni għall-antibijotiċi ċitostatiċi: hija taħlita ta' antibijotiċi glikopeptidi strutturalment relatati, alkalini, li jdubu fl-ilma b'effett ċitostatiku.
English: Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, and adopted the totality of the proposed indications, for Bleomycin Pharmachemie:
Maltese: Għaldaqstant, is-CHMP huwa tal-opinjoni li l-bleomiċina xorta għadu mediċina kemjoterapewtika valida, u adotta l-indikazzjonijiet proposti kollha għal Bleomycin Pharmachemie:
English: Local/Intratumoral injections
Maltese: Injezzjonijiet lokali/ġot-tumur
English: Bleomycin Teva, Pulver og væske til injeksjonsvæske, oppløsning
Maltese: og væske til injeksjonsvæske, oppløsning
English: Bleomycin „Pharmachemie“ 15000 I.E. - Pulver zur Herstellung einer Injektionslösung
Maltese: Bleomycin „Pharmachemie“ 15000 I.E.
English: Route of administration
Maltese: Swensweg 5
English: Because the benefit/risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Maltese: Minħabba li l-valutazzjoni ta' benefiċċju/riskju għal dawn l-indikazzjonijiet kienet waħda negattiva għall-prodott oriġinatur u minħabba li l-indikazzjonijiet ġew konsegwentament imħassrin millindikazzjonijiet awtorizzati għall-prodotti kollha li fihom il-bleomiċina fil-Ġermanja, l-indikazzjonijiet tqiesu bħala indikazzjonijiet ġodda, u l-Istat Membru li oġġezzjona kkunsidra li d-dejta sottomessa ma kinitx biżżejjed biex tingħata awtorizzazzjoni għat-tqegħid fis-suq għall-indikazzjonijiet ġodda proposti.
English: In a lower degree bleomycin also affects the RNA and protein synthesis.
Maltese: Fi grad iktar baxx, il-bleomiċina taffettwa wkoll l-RNA u s-sinteżi tal-proteini.
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections
Maltese: Għoti ġol-arterja Injezzjoni ġol-plewra Injezzjonijiet lokali/ġot-tumur
English: The CHMP assessed the available data in order to establish whether the two indications can be supported.
Maltese: Is-CHMP ivvaluta d-dejta disponibbli sabiex jistabbilixxi jekk iż-żewġ indikazzjonijiet jistgħux jiġu appoġġjati.
English: - Squamous cell carcinoma of Head and neck (SCCHN) - Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
Maltese: Rigward l-indikazzjoni ta' karċinoma epidermojde tal-ġenitali esterni, is-CHMP innota li l-bleomiċina bħalissa xorta għadha tintuża f'kanċer taċ-ċerviċi, u sar qbil fuq il-fatt li għalkemm l-effikaċja klinika hija modesta f'din l-indikazzjoni, kif ukoll f'kanċer tal-pene, diversi provi reċenti wrew is-sinifikat talbleomiċina f'dawn l-indikazzjonijiet.