FrancophonIA/ELRC3.0 huggingface dataset:
English: Thereafter, vitamin A supplementation of 3000 IU per day should be resumed in the second and third trimester if plasma retinol levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Maltese: Wara dan, għandha titkompla supplimentazzjoni tal-vitamina A ta' 3000 IU kuljum fit-tieni u t-tielet trimestru jekk il-livelli ta' retinol fil-plażma ma jkunux għadhom irritornaw għan-normal, minħabba r-riskju miżjud ta' defiċjenza tal-vitamina A fit-tielet trimestru..
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 284 mg inotersen (as sodium).
Maltese: Kull siringa mimlija għal-lest fiha 284 mg inotersen (bħala sodium).
English: Tray with tear-off lid.
Maltese: Huma rrakkomandati lkortikosterojdi.
English: This reaction typically resolves spontaneously after a few days of treatment.
Maltese: Din ir-reazzjoni tipikament tfiq spontanjament wara ftit jiem ta' kura.
English: You should resume the vitamin A supplementation during your second and third trimesters of your pregnancy if your vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Maltese: Għandek tkompli s-supplimentazzjoni tal-vitamina A waqt it-tieni u t-tielet trimestri tiegħek tat-tqala tiegħek jekk il-livelli tal-vitamina A tiegħek ikunu għadhom ma rritornawx għan-normal, minħabba r-riskju miżjud ta' defiċjenza tal-vitamina A fit-tielet trimestru.
English: Hepatic enzymes should be measured 4 months after initiation of treatment with inotersen and annually thereafter or more frequently as clinically indicated, in order to detect cases of hepatic impairment (see section 4.8).
Maltese: L-enzimi tal-fwied għandhom jitkejlu 4 xhur wara l-bidu ta' kura b'inotersen u kull sena wara dan jew aktar frekwenti kif indikat klinikament, sabiex jiġu identifikati każijiet ta' indeboliment tal-fwied (ara sezzjoni 4.8).
English: See Section 4.8 for how to report adverse reactions
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Patients were randomised 2:1 to receive either inotersen or placebo.
Maltese: Il-pazjenti ġew randomizzati 2:1 sabiex jirċievu jew inotersen jew il-plaċebo.
English: Still, no effect on embryo-foetal development was noted with a mouse-specific analogue of inotersen in mice, which was associated with ~60% inhibition (individual range up to 90% reduction) of TTR mRNA expression.
Maltese: Xorta waħda, ma ġie nnutat l-ebda effett fuq l-iżvilupp tal-embrijun/tal-fetu b'analoga speċifika għall-ġurdien fil-ġrieden, li ġiet assoċjata ma' inibizzjoni ta' ~60% (medda individwali sa tnaqqis ta' 90%) tal-espressjoni TTR mRNA.
English: A responder analysis of mNIS+7 using thresholds ranging from a 0- to 30-point increase from baseline (using the safety set), showed the inotersen group had approximately a 2-fold higher response rate than the placebo group at each threshold tested, demonstrating consistency of response.
Maltese: Analiżi tar-rispondenti ta' mNIS+7 permezz ta' limiti li jvarjaw minn żieda ta' 0- sa 30-punt mil-linja bażi (permezz tas-sett tas-sigurtà), uriet li l-grupp ta' inotersen kellhom madwar rata tar-rispons ta' darbtejn aktar mill-grupp tal-plaċebo f'kull limitu ttestjat, billi ntweriet konsistenza tar-rispons.
English: Tegsedi 284 mg solution for injection in pre-filled syringe inotersen
Maltese: Tegsedi 284 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest inotersen
English: Statistical significance in favour of inotersen was demonstrated at all thresholds beyond a 0-point change.
Maltese: Intweriet sinifikanza statistika favur inotersen fil-limiti kollha lil hinn minn bidla ta' 0- punti.
English: Influenza like illness Peripheral swelling Injection site discolouration
Maltese: Mard simili għall-influwenza Nefħa periferali Skulurament fis-sit talinjezzjoni
English: Baseline demographic and disease characteristics are shown in Table 3.
Maltese: Il-karatteristiċi demografiċi fil-linja bażi u tal-marda huma murija f'Tabella 3.
English: The disease hATTR-PN is classified into 3 stages such that i) Stage 1 patients do not require assistance with ambulation, ii) Stage 2 patients do require assistance with ambulation, and iii) Stage 3 patients are bound to wheelchair.
Maltese: Il-marda hATTRPN hija kklassifikata fi 3 stadji b'tali mod li i) pazjenti fi Stadju 1 ma jeħtiġux għajnuna flambulazzjoni, ii) pazjenti fi Stadju 2 jeħtieġu għajnuna fl-ambulazzjoni, u iii) pazjenti fi Stadju 3 jużaw siġġu tar-roti.
English: • Advise HCPs that, due to the risks of thrombocytopenia and glomerulonephritis, patients should have their platelet count monitored at least every 2 weeks, and urine to protein creatinine ratio and estimated glomerular filtration rate monitored at least every 3 months;
Maltese: • twissi lill-HCPs li, minħabba r-riskji ta' tromboċitopenija u glomerulonefrite, għandu jsir monitorġġ tal-għadd tal-plejtlits tal-pazjenti għallinqas kull ġimagħtejn, u l-proporzjon talkreatinina għall-proteina fl-awrina u r-rata ta' filtrazzjoni glomerulari stmata għandhom jiġu mmonitorjati mill-inqas kull 3 xhur;
English: Eosinophilia
Maltese: Parti ewlenija
English: • Advise HCPs that if glomerulonephritis is confirmed, Tegsedi treatment should be permanently discontinued and early initiation of immunosuppressive therapy should be considered.
Maltese: • tagħti l-parir lill-HCPs li jekk tiġi kkonfermata glomerulonefrite, il-kura b'Tegsedi għandha titwaqqaf b'mod permanenti u għandu jiġi kkunsidrat bidu kmieni ta' terapija immunosuppressiva.
English: Patients with UPCR more than or equal to twice the upper limit of normal, or eGFR < 60 ml/min, which is confirmed on repeat testing and in the absence of an alternative explanation, should be monitored every 4 weeks.
Maltese: Pazjenti b'UPCR aktar minn jew daqs darbtejn il-limitu massimu tan-normal, jew eGFR < 60 ml/min, li jiġi kkonfermat minn ittestjar ripetut u fin-nuqqas ta' spjegazzjoni alternattiva, għandhom jiġu mmonitorjati kull 4 ġimgħat.
English: In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Maltese: F'każ ta' doża eċċessiva, għandha tiġi pprovduta kura medika ta' sostenn inkluż konsultazzjoni ma' professjonist tal-kura tas-saħħa u osservazzjoni mill-qrib tal-istatus kliniku tal-pazjent.
English: Renal impairment
Maltese: Itwi u ċarrat
English: - Each pre-filled syringe contains 284mg of inotersen.
Maltese: U MNEJN GĦANDU JINGĦATA Tegsedi 284 mg injezzjoni inotersen
English: The MAH shall ensure that in each MS where Tegsedi is marketed, all patients who are expected to been administered the products are provided with a patient alert card (wallet size), aiming at preventing and/or minimising the important identified risks of thrombocytopenia, glomerulonephritis, and the important potential risk of ocular toxicity due to vitamin A deficiency, and reminding patients:
Maltese: Il-MAH għandu jiżgura li f'kull SM fejn Tegsedi jkun se jitpoġġa fis-suq, il-pazjenti kollha li huma mistennija li jingħataw il-prodotti, jiġu pprovduti b'kard ta' twissija għall-pazjent (daqs ta' kartiera), li għandha l-għan li timpedixxi u/jew li timminimizza r-riskji identifikati importanti ta' tromboċitopenija, glomeruulonefrite, u r-riskju potenzjali importanti ta' tossiċità okulari dovuta għal nuqqas ta' vitamina A, u għandha tfakkar lill-pazjenti:
English: (haematoma) - Itching - Rash - Kidney damage leading to poor kidney function or kidney failure - Changes to your blood and urine test results (this may indicate infection or liver or kidney damage) - Flu like symptoms, such as high temperature, aches and chills (influenza-like illness) - Injection site swelling or skin discolouration
Maltese: ipotensjoni) - Tbenġil - Ġabra ta' demm fit-tessuti, li tista' tidher simili għal tbenġil sever (ematoma) - Ħakk - Raxx - Ħsara fil-kliewi li twassal għal funzjoni tal-kliewi batuta jew insuffiċjenza tal-kliewi - Tibdil fir-riżultati tad-demm jew tal-awrina tiegħek (dan jista' jindika infezzjoni jew ħsara fil fwied jew fil-kliewi) - Sintomi bħal tal-influwenza, bħal temperatura għolja, uġigħ u dehxiet ta' bard (mard bħal dak tal-influwenza) - Nefħa jew skulurament tal-ġilda fis-sit tal-injezzjoni
English: Inotersen will reduce the plasma levels of vitamin A, which is crucial for normal foetal development.
Maltese: Inotersen ser inaqqas il-livelli tal-vitamina A fil-plażma, li huwa kruċjali għal żvilupp normali tal-fetu.
English: Because of the risk of glomerulonephritis and possible renal function decline, UPCR and eGFR should be monitored during treatment with inotersen (see section 4.4).
Maltese: Minħabba r-riskju ta' glomerulonefrite u tnaqqis possibbli fil-funzjoni tal-kliewi, UPCR u eGFR għandhom jiġu mmonitorjati waqt kura b'inotersen (ara sezzjoni 4.4).
English: In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment.
Maltese: Fl-istudju pivotali ta' Fażi 2/3, 30.4 % tal-pazjenti kkurati b'inotersen ittestjaw pożittivi għal antikorpi kontra l-mediċina wara 15-il xahar ta' kura.
English: Platelet count, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR) and hepatic enzymes should be measured prior to treatment with Tegsedi.
Maltese: L-għadd tal-pjastrini, ir-rata tal-filtrazzjoni glomerulari stmata (eGFR), il-proporzjon ta' proteina għal kreatinina fl-awrina (UPCR) u l-enzimi tal-fwied għandhom jitkejlu qabel kura b'Tegsedi.
English: Plasma vitamin A (retinol) levels below lower limit of normal should be corrected and any ocular symptoms or signs of vitamin A deficiency should have resolved prior to initiation of inotersen.
Maltese: Livelli tal-vitamina A (retinol) fil-plażma taħt il-limitu anqas min-normal għandhom jiġu korretti u kwalunkwe sintomu jew sinjal okulari ta' defiċjenza tal-vitamina A għandu jiġi riżolt qabel il-bidu ta' inotersen.
English: Tegsedi may pass into breast milk.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tegsedi 284 mg injection inotersen
Maltese: - Kull siringa mimlija għal-lest fiha 284 mg ta' inotersen.
English: There is no information available on the effects of inotersen on human fertility.
Maltese: M'hemmx informazzjoni disponibbli dwar l-effetti ta' inotersen fuq il-fertilità tal-bniedem.
English: What you need to know before you use Tegsedi Do not use Tegsedi if: - you are allergic to inotersen or any of the other ingredients of this medicine (listed in section - tests show you have excessively low numbers of platelets, the cells in your blood which stick together helping it clot - tests of kidney function or protein in the urine show signs of severe kidney problems - you have severe reduction in liver function (hepatic impairment) Warnings and precautions Before you begin treatment with Tegsedi, your doctor will measure your blood cells, liver function, kidney function, and protein levels in your urine.
Maltese: - it-testijiet juru li għandek numri baxxi b'mod eċċessiv tal-pjastrini, iċ-ċelluli fid-demm tiegħek li jeħlu flimkien biex jgħinuh jagħqad - it-testijiet tal-funzjoni tal-kliewi jew tal-proteina fl-awrina juru sinjali ta' problemi fil-kliewi severi - għandek tnaqqis sever fil-funzjoni tal-fwied (indeboliment tal-fwied)
English: Based on the population pharmacokinetic analysis, age, body weight, sex or race has no clinically relevant effect on inotersen exposure.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, l-età, il-piż tal-ġisem, is-sess jew ir-razza m'għandhom l-ebda effett klinikament rilevanti fuq l-esponiment ta' inotersen.
English: Then monitor twice weekly until 3 successive values above 75.
Maltese: Imbagħad immonitorja darbtejn f'ġimgħa sa 3 valuri suċċessivi 'l fuq minn 75.
English: Twice weekly until 3 successive values above 75 then weekly monitoring.
Maltese: Darbtejn fil-ġimgħa sa 3 valuri suċċessivi 'l fuq minn 75 imbagħad monitoraġġ kull ġimgħa.
English: - Symptoms that could indicate thrombocytopenia (where blood will not clot), such as unexplained bruising or a rash of small patches of red appearing on the skin (called petechiae), bleeding from skin cuts that does not stop or oozes, bleeding from the gums or nose, blood in urine or stools, or bleeding in the whites of your eyes.
Maltese: - Is-sintomi jistgħu jindikaw glomerulonefrite, (fejn il-kliewi tiegħek ma jaħdmux kif suppost), bħal awrina bir-ragħwa, awrina kulur roża jew kannella, demm fl-awrina, u tgħaddi inqas awrina mis-soltu.
English: No data are available in patients with severe renal impairment.
Maltese: Huwa normali li tara bżieżaq talarja fis-soluzzjoni.
English: Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Maltese: Għandha tintuża l-kawtela bi prodotti mediċinali nefrotossiċi u prodotti mediċinali oħra li jistgħu jindebolaw il-funzjoni tal-kliewi (ara sezzjoni 4.5).
English: If you stop taking Tegsedi then your blood levels should be checked 8 weeks after discontinuation.
Maltese: Jekk tieqaf tieħu Tegsedi, il-livelli tad-demm tiegħek għandhom jiġu ċċekkjati 8 ġimgħat wara t-twaqqif.
English: Chills
Maltese: TWISSIJIET
English: Patients should be monitored for thrombocytopenia during treatment with inotersen (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għattromboċitopenja waqt kura b'inotersen (ara sezzjoni 4.4).
English: This suggests an immunologically related mechanism.
Maltese: Dan jissuġġerixxi mekkaniżmu relatat immunoloġikament.
English: Early initiation of immunosuppressive therapy should be considered if a diagnosis of glomerulonephritis is confirmed.
Maltese: Għandu jiġi kkunsidrat bidu kmieni ta' terapija immunosoppressiva jekk tiġi kkonfermata dijanjożi ta' glomerulonefrite.
English: No effect on the pharmacokinetic properties (Cmax, AUC or half-life) and efficacy of inotersen was observed in the presence of anti-drug antibodies, but patients with anti-drug antibodies had more reactions at the injection site.
Maltese: Ma ġie osservat l-ebda effett fuq il-proprjetajiet farmakodinamiċi (Cmax, AUC jew nofs ħajja) u l-effikaċja ta' inotersen fil-preżenza ta' antikorpi kontra l-mediċina, iżda l-pazjenti b'antikorpi kontra l-mediċina kellhom aktar reazzjonijiet fis-sit tal-injezzjoni.
English: - Any medicines that may alter your kidney function or may damage the kidneys, e.g., sulfonamides (used as an antibacterial), anilides (used to treat fever, aches and pains), aldosterone antagonists (used as a diuretic) and natural opium alkaloids and other opiods (used for treatment of pain).
Maltese: - Kwalunkwe mediċina li tista' tibdel il-funzjoni tal-kliewi tiegħek jew tagħmel il-ħsara lillkliewi, eż., sulfonamidi (li jintużaw bħala antibatteriku), anilidi (li jintużaw biex jikkuraw deni u uġigħ), antagonisti ta' aldosterone (li jintużaw bħala dijuretiku) u alkalojdi tal-oppju naturali u opjojdi oħra (li jintużaw għall-kura tal-uġigħ).
English: Glomerulonephritis / renal function decline
Maltese: Glomerulonefrite/ tnaqqis fil-funzjoni tal-kliewi
English: Following subcutaneous administration, inotersen is absorbed rapidly into systemic circulation in a dose-dependent fashion with the median time to maximum plasma concentrations (Cmax) of inotersen typically reached within 2 to 4 hours.
Maltese: Wara għoti taħt il-ġilda, inotersen jiġi assorbit malajr fiċ-ċirkolazzjoni sistemika b'mod dipendenti mid-doża biż-żmien medjan sal-konċentrazzjonijiet massimi fil-plażma (Cmax) ta' inotersen li tipikament jintlaħqu fi żmien sagħtejn sa 4 sigħat.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of inotersen metabolites in milk (see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni tal-metaboliti ta' inotersen fil-ħalib tas-sider (ara 5.3). Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: Platelet count < 100 x 10
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10)
English: Do not remove any air bubbles from the pre-filled syringe.
Maltese: Aħsel idejk bis-sapun u bl-ilma.
English: Tabulated summary of adverse reactions
Maltese: Deskrizzjoni tar-reazzjonijiet avversi magħżula
English: Therefore, reduction in plasma TTR is expected to result in reduction of plasma retinol levels to below the lower limit of normal.
Maltese: Għalhekk, tnaqqis fit-TTR fil-plażma huwa mistenni li jirriżulta fi tnaqqis fil-livelli ta' retinol fil-plażma għal taħt il-limitu anqas min-normal.
English: Contacera meloxicam
Maltese: Contacera meloksikam
English: It is available as a solution for injection (20 mg/ml) and an oral suspension (15 mg/ml).
Maltese: Jiġi f'soluzzjoni għall-injezzjoni (20 mg/ml) u sospensjoni orali (15 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Contacera on 6 December 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Contacera fis-6 ta' Diċembru 2012.
English: Horses
Maltese: Frat
English: Contacera is a medicine that contains the active substance meloxicam.
Maltese: Contacera huwa mediċina li fiha s-sustanza attiva meloksikam.
English: Other information about Contacera:
Maltese: Informazzjoni oħra dwar Contacera:
English: Contacera is a ‘generic', which means that Contacera is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Maltese: Contacera huwa ‘ġeneriku', jiġifieri simili għal ‘mediċina veterinarja ta' referenza' li diġà hija awtorizzata fl-UE (Metacam).
English: Side effects that occurred with the oral suspension in horses included isolated cases of adverse reactions typically associated with NSAIDs (slight urticaria and diarrhoea).
Maltese: L-effetti sekondarji li kien hemm fis-sospensjoni orali fiż-żwiemel inkludiet każijiet iżolati ta' reazzjonijiet avversi tipikament assoċjati mal-NSAIDs (urtikarja ħafifa u dijarrea).
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Maltese: Il-meloksikam taġixxi billi timblokka enzima msejħa ċiklo-ossiġenażi li hija involuta fil-produzzjoni tal-prostaglandina.
English: Contacera is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Maltese: Contacera jintuża fil-bhejjem tal-ifrat, flimkien ma' terapija antibijotika adatta, għat-tnaqqis ta' sintomi kliniċi f'infezzjoni respiratorja akuta (infezzjoni tal-pulmun u l-passaġġi tal-arja) u għat-trattament talmastite akuta (infjammazzjoni tal-glandola mammarja).
English: Contacera contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Contacera fih il-meloksikam, li jappartjeni għall-klassi ta' mediċini msejħin mediċini antinfjammatorji mhux sterojdali (NSAIDs).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ benefiċċju riskju jista' jinstab filmodulu tad-diskussjoni xjentifika f'dan l-EPAR.
English: In pigs, Contacera is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Maltese: Contacera jintuża biex jitnaqqsu s-sintomi taz-zappip u l-infjammazzjoni f'disturbi mhux infettivi talmixi (mard li jaffettwa l-abbiltà tal-mixi) u għal terapija ta' appoġġ flimkien mat-terapija antibijotika xierqa fil-kura tal-mard wara t-tifrigħ (il-ħlas) bħas-settiċemija pwerperali u t-tossjemija (is-sindromu tal-mastite-metrite-agalassija).
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni dwar il-bażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: How has Contacera been studied?
Maltese: Kif ġie studjat Contacera?
English: For meat the withdrawal period with the 20 mg/ml solution for injection is five days and with the 15 mg/ml oral suspension it is three days.
Maltese: Għas-soluzzjoni għat-titqiba ta' 20 mg/ml il-perjodu ta' tiżmim għal-laħam huwa ħamest ijiem, u għassoluzzjoni orali ta' 15 mg/ml huwa tlett ijiem.
English: Why has Contacera been approved?
Maltese: Għaliex ġie approvat Contacera?
English: What is the risk associated with Contacera?
Maltese: X'inhu r-riskju assoċjat ma' Contacera?
English: Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine.
Maltese: Abbażi tar-riżultati tal-istudji, Contacera tqies bijoekwivalenti għall-mediċina ta' referenza.
English: What is Contacera?
Maltese: Kif jaħdem Contacera?
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
Maltese: F'każi rari ħafna ġew irrappurtati effetti sekondarji oħrajn bħal telf tal-aptit, letarġija, uġigħ addominali u kolite (infjammazzjoni tal-parti saflenija talimsaren).
English: Symptoms were reversible.
Maltese: Dawn is-sintomi kienu riversibbli.
English: People who are hypersensitive to NSAIDs should avoid contact with Contacera.
Maltese: Il-persuni li huma ipersensittivi għall-NSAIDs għandhom jevitaw il-kuntatt ma' Contacera.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Peress li l-prostaglandini huma sustanzi li jiskattaw linfjamazzjoni, l-uġigħ, it-tagħriq (fluwidu fl-għamla ta' għaraq li joħroġ mill-vini matul l-infjamazzjoni) u d-deni, il-melossikam tnaqqas is-sinjali tal-mard.
English: Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances (toxins).
Maltese: Is-settiċemija u t-tossjemija huma kundizzjonijiet fejn fid-demm jiċċirkulaw batterji li jipproduċu sustanzi perikolużi (tossini).
English: Age (y)
Maltese: Età (y)
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - 2D BARCODE
English: - The active substance is vinflunine.
Maltese: - Is-sustanza attiva hi vinflunine.
English: F-64320 Idron
Maltese: F-64320
English: System Organ Class
Maltese: Klassi tas-Sistema talOrganu
English: Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2009 Data tal-aħħar tiġdid: 16 ta' Mejju 2014