FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina serji komuni fil-popolazzjoni b'RCC (inċidenza ta' ≥1%) huma dijarea, pressjoni għolja, deidratazzjoni, iponatrimija, dardir, tnaqqis fl-aptit, emboliżmu, għeja kbira,
English: Not known (proportion of people affected not known)
Maltese: Mhux magħruf (proporzjon ta' persuni affettwati mhux magħruf)
English: Film-coated tablet.
Maltese: Tfarrakx ilpilloli.
English: Contents of the pack and other information What CABOMETYX contains The active substance is cabozantinib (S)-malate.
Maltese: Is-sustanza attiva hi cabozantinib (S)-malate.
English: Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Maltese: Pazjenti li għandhom mard infjammatorju tal-imsaren (eż., il-marda ta' Crohn, kolite ulċerattiva, peritonite, divertikulite, jew appendiċite), li għandhom infiltrazzjoni tat-tumur fil-passaġġ GI, jew li għandhom komplikazzjonijiet minn kirurġija GI li saret qabel (b'mod partikolari meta assoċjata ma fejqan ittardjat jew mhux komplut), għandhom jiġu evalwati b'attenzjoni qabel ma tinbeda terapija b'cabozantinib u sussegwentement għandhom jiġu monitorati mill-qrib għal sintomi ta' perforazzjonijiet u fistuli inklużi axxessi u sepsis.
English: Randomization was stratified by aetiology of disease (HBV [with or without HCV], HCV [without HBV], or other), geographic region (Asia, other regions) and by presence of extrahepatic spread of disease and/or macrovascular invasions (Yes, No).
Maltese: Randomisation ġiet stratifikata skont l-etjoloġija tal-marda (HBV [b'HCV jew mingħajru], HCV [mingħajr HBV], jew oħra), ir-reġjun ġeografiku (Asja, reġjuni oħra) u skont il-preżenza ta' firxa ekstraepatika tal-marda u/jew invażjonijiet makrovaskulari (Iva, Le).
English: Wound complications
Maltese: Mhux Komuni
English: Institut Produits Synthèse (IPSEN) AB Kista Science Tower Färögatan 33
Maltese: Kista Science Tower
English: Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Maltese: Cabozantinib kien evalwat għall-attività inibitorja tiegħu kontra varjetà ta' kinases u kien identifikat bħala inibitur ta' MET (proteina tar-riċettur talfattur tat-tkabbir tal-epatoċiti) u tar-riċetturi ta' VEGF (fattur tat-tkabbir tal-endotelju vaskulari).
English: In a subsequent unplanned interim analysis of OS, a statistically significant improvement was demonstrated for patients randomized to CABOMETYX as compared with everolimus (320 events, median of 21.4 months vs. 16.5 months; HR=0.66 [0.53, 0.83], p=0.0003; Figure 2).
Maltese: F'analiżi interim sussegwenti mhux ippjanata ta' OS, titjib statistikament sinifikanti intwera għall-pazjenti randomised għal CABOMETYX meta mqabbel ma' everolimus (320 avveniment, medjan ta' 21.4 xhur kontra 16.5 xhur;
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti li jiżviluppaw sindrome nefrotiku.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
Maltese: Il-karatteristiċi demografiċi u tal-marda fil-linja bażi kienu simili bejn il-gruppi ta' CABOMETYX u everolimus.
English: Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant thromboembolic complication.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti li jiżviluppaw infart mijokardijaku akut jew kwalunkwe komplikazzjoni tromboembolika oħra sinifikanti klinikament.
English: ORR (partial responses only) (95% CI) p-value1
Maltese: ORR (rispons parzjali biss) (CI ta' valur p1
English: Persistent or recurring diarrhoea while on treatment may be a risk factor for the development of anal fistula.
Maltese: Dijarea persistenti jew rikorrenti waqt it-trattament tista' tkun fattur ta' riskju għall-iżvilupp ta' fistula anali.
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Maltese: Kull pillola fiha cabozantinib (S)-malate ekwivalenti għal 40 mg cabozantinib.
English: Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Maltese: (eż., ritonavir, itraconazole, erythromycin, clarithromycin, meraq tal-grejpfrut) flimkien ma' cabozantinub għandu jsir b'kawtela.
English: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
Maltese: Kull pillola fiha cabozantinib (S)-malate ekwivalenti għal 60 mg cabozantinib.
English: Probability of Progression-Free Survival
Maltese: Marda stabbli Marda Progressiva
English: Hypertension was observed more frequently in the treatment naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy
Maltese: Pressjoni għolja kienet osservata b'mod aktar frekwenti fil-popolazzjoni b'RCC li ma kinux ittrattati qabel (67%) mqabbla ma' pazjenti b'RCC wara terapija preċedenti mmirata lejn VEGF
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the HCC population included diarrhoea, palmar-plantar erythrodysaesthesia syndrome, fatigue, decreased appetite hypertension and nausea.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti ta' kwalunkwe grad (li esperjenzaw mill-inqas 25% tal-pazjenti) filpopolazzjoni b'HCC kienu jinkludu dijarea, is-sindrome ta' eritrodisasteżija palmari-plantari, għeja, tnaqqis fl-aptit, pressjoni għolja u dardir.
English: Predisposing risk factors for severe haemorrhage in the advanced HCC population may include tumour invasion of major blood vessels and the presence of underlying liver cirrhosis resulting in oesophageal varices, portal hypertension, and thrombocytopenia.
Maltese: Il-fatturi ta' riskju li jipredisponu għal emorraġija severa fil-popolazzjoni b'HCC avanzata jistgħu jinkludu invazjoni mit-tumur ta' kanali tad-demm prinċipali u l-preżenza ta' ċirrożi sottostanti tal-fwied li twassal għal variċi tal-esofagu, pressjoni portali għolja, u tromboċitopenija.
English: Therefore, chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Maltese: Għalhekk, għoti kroniku ta' sustanzi li huma indutturi qawwija ta' CYP3A4 ma' cabozantinib għandu jiġi evitat (ara sezzjonijiet 4.2 u 4.5).
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Maltese: Fil-firien, cabozantinib ikkaġuna telf wara l-impjantazzjoni, edima fil-fetu, palat/xoffa maqsuma, aplasja dermali u denb mgħawweġ jew rudimentali.
English: • Anaemia (low levels of red blood cells)
Maltese: • Anemija (livelli baxxi ta' ċelluli ħomor tad-demm)
English: HBV], or Other), geographic region (Asia, Other Regions), and presence of extrahepatic spread of disease and/or macrovascular invasion (Yes, No) as stratification factors (per IVRS data) 2 estimated using the Cox proportional-hazard model 3 as assessed by investigator per RECIST 1.1
Maltese: HBV], jew Oħra), reġjun ġeografiku (Asja, Reġjuni Oħra), u preżenza ta' firxa ekstraepatika tal-marda u/jew invażjoni makrovaskulari (Iva, Le) bħala fatturi ta' stratifikazzjoni (skont data
English: CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Maltese: CABOMETYX jimblokka l-azzjoni ta' proteini msejjħa tyrosine kinases tar-riċetturi (RTKs - receptor tyrosine kinases), li huma nvoluti fit-tkabbir taċ-ċelluli u l-iżvilupp ta' kanali tad-demm ġodda li jfornuhom.
English: When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Maltese: Meta jkun meħtieġ tnaqqis fid-doża, huwa rakkomandat li titnaqqas għal 40 mg kuljum, u mbagħad għal 20 mg kuljum.
English: Gastric pH modifying agents
Maltese: Sustanzi li jimmodifikaw l-pH tal-istonku
English: The safety and efficacy of CABOMETYX for the treatment of renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy were evaluated in a randomized, openlabel, multicenter Phase 3 study (METEOR).
Maltese: Is-sigurtà u l-effikaċja ta' CABOMETYX għat-trattament ta' karċinoma taċ-ċellula renali wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskulari (VEGF - vascular endothelial growth factor) kienu evalwati fi studju ta' Fażi 3 randomised, open-label u b'aktar minn ċentru wieħed (METEOR).
English: An exploratory OS analysis censoring for the use of NPACT supported the primary analysis: the HR, adjusted for stratification factors (per IxRS), was 0.66 (95% CI: 0.52, 0.84; stratified logrank p-value = 0.0005).
Maltese: IxRS), kien ta' 0.66 (CI ta' 95%, 0.84; valur p log-rank stratifikat = 0.0005).
English: CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Maltese: CABOMETYX pilloli miksija b'rita ta' 20 mg Kull pillola miksija b'rita fiha cabozantinib (S)-malate ekwivalenti għal 20 mg cabozantinib.
English: Renal and urinary disorders proteinuria
Maltese: Disturbi fil-kliewi u fis-sistema urinarja proteina fl-awrina
English: There is a possibility your fertility could be affected by treatment with CABOMETYX.
Maltese: Hemm possibilità li l-fertilità tiegħek tista' tiġi affettwata bit-trattament tiegħek b'CABOMETYX.
English: CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with “XL” on one side and “40” on the other side.
Maltese: CABOMETYX 40 mg pilloli miksija b'rita huma sofor, b'forma ta' trijanglu mingħajr sinjal imnaqqax, u identifikati b'“XL” fuq naħa waħda u “40” fuq in-naħa l-oħra.
English: ANNEX II
Maltese: Tabella 5:
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib
Maltese: CABOMETYX 40 mg pilloli miksija b'rita cabozantinib ISEM
English: The tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet.
Maltese: Il-pilloli huma sofor, għandhom forma ovali mingħajr sinjal imnaqqax, u mnaqqxa b'“XL” fuq naħa waħda u “60” fuq in-naħa l-oħra tal-pillola.
English: • Pain in arms, legs and joints, muscle spasms
Maltese: • Uġigħ fl-idejn, fis-saqajn u l-ġogi, spażmi fil-muskoli
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution of the central compartment (Vc/F) was estimated to be 212 L. Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Maltese: Abbażi tal-mudell talfarmakokinetika tal-popolazzjoni (PK - population-pharmacokinetic), il-volum ta' distribuzzjoni talkompartiment ċentrali (Vc/F) kien stmat bħala 212 L.
English: Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
Maltese: Tabella 1: Rakkomandazzjoni ta' modifikazzjonijiet fid-doża ta' CABOMETYX minħabba reazzjonijiet avversi
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Maltese: Mhux indikat aġġustament fiddoża meta sustanzi li jimmodifikaw il-pH tal-istonku (jiġifieri, PPIs, antagonisti tar-riċettur H2, u antaċidi) jingħataw flimkien ma' cabozantinib.
English: - have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall - have diarrhoea - have a recent history of significant bleeding - have had surgery within the last month (or if surgical procedures are planned), including dental surgery - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis,
Maltese: - għandek pressjoni għolja - għandek jew kellek anewriżmu (tkabbir u dgħufija ta' ħajt ta' vina) jew tiċrita f'ħajt ta' vina. - għandek dijarea - għandek storja medika reċenti ta' fsada sinifikanti - kellek kirurġija fl-aħħar xahar (jew jekk huma ppjanati proċeduri kirurġiċi), inkluża kirurġija fis snien - għandek marda infjammatorja tal-imsaren (pereżempju, il-marda ta' Crohn jew kolite ulċerattiva,
English: Patients with a history of portal vein invasion appeared to be at higher risk of developing portal vein thrombosis.
Maltese: Pazjenti bi storja ta' invażjoni fil-vina portali dehru li huma f'riskju akbar li jiżviluppaw trombożi fil-vina portali.
English: The safety and efficacy of CABOMETYX for the treatment of treatment-naïve renal cell carcinoma were evaluated in a randomized, open-label, multicenter study (CABOSUN).
Maltese: Is-sigurtà u l-effikaċja ta' CABOMETYX għat-trattament ta' karċinoma taċ-ċellula renali li qatt ma ġiet ittrattata qabel kienu evalwati fi studju randomised, open-label u b'aktar minn ċentru wieħed (CABOSUN).
English: If you take CABOMETYX whilst using oral contraceptives, the oral contraceptives may be ineffective.
Maltese: Jekk tieħu CABOMETYX waqt li tkun qed tuża kontraċettivi orali, il-kontraċettivi orali jistgħu ma jkunux effettivi.
English: Primary PFS analysis Population Intent-To-Treat Population
Maltese: Popolazzjoni ta' analiżi Primarja tal-PFS
English: CABOMETYX 60 mg film-coated tablets
Maltese: CABOMETYX 60 mg pilloli miksija b'rita
English: CABOMETYX 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Maltese: Kull pillola fiha cabozantinib (S)-malate ekwivalenti għal 20 mg cabozantinib.
English: Platelet levels should be monitored during cabozantinib treatment and the dose modified according to the severity of the thrombocytopenia (see Table 1).
Maltese: Il-livelli talplejtlits għandhom jiġu mmonitorjati matul it-trattament b'cabozantinib u d-doża għandha tiġi mmodifikata skont is-severità tat-tromboċitopenija (ara t-Tabella 1).
English: What CABOMETYX is
Maltese: X'fih CABOMETYX
English: Because of the potential harm to the infant, mothers should discontinue breast-feeding during treatment with cabozantinib, and for at least 4 months after completing therapy.
Maltese: Minħabba l-ħsara potenzjali għat-tarbija, l-ommijiet għandhom iwaqqfu t-treddigħ waqt trattament b'cabozantinib, u għal tal-anqas 4 xhur wara li jtemmu t-terapija.
English: • Fatigue, weakness, headache, dizziness
Maltese: • Għeja, dgħufija, uġigħ ta' ras, sturdament
English: CABOMETYX 40 mg film-coated tablets
Maltese: CABOMETYX 40 mg pilloli miksija b'rita
English: Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Maltese: Tabella 3: Sommarju ta' sejbiet ta' PFS minn kumitat ta' analiżi radjoloġika indipendenti f'individwi b'RCC wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskulari (VEGF
English: Bile salt-sequestering agents such as cholestyramine and cholestagel may interact with cabozantinib and may impact absorption (or reabsorption) resulting in potentially decreased exposure (see section 5.2).
Maltese: Sustanzi li jissekwestraw l-imluħa tal-bila bħal cholestyramine u cholestagel jistgħu jirreaġixxu ma' cabozantinib u jistgħu jħallu impatt fuq l-assorbiment (jew l-assorbiment mill-ġdid) li jwassal għal esponiment potenzjalment imnaqqas (ara sezzjoni 5.2).
English: Median time to onset was 5.9 weeks.
Maltese: Iż-żmien medjan sal-bidu kien ta' 5.9 ġimgħat.
English: CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Maltese: CABOMETYX huwa indikat bħala monoterapija għat-trattament ta' karċinoma epatoċellulari (HCChepatocellular carcinoma) f'adulti li ġew ittrattati b'sorafenib fil-passat.
English: Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Maltese: Disturbi vaskulari pressjoni għolja, emorraġija trombożi fil-vini trombożi fl-arterji anewriżmi u dissezzjonijiet talarterji
English: CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
Maltese: Kull pillola fiha cabozantinib (S)-malate ekwivalenti għal 60 mg ta' cabozantinib.
English: No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
Maltese: Ma kinux irrappurtati każijiet ta' enċefalopatija tal-fwied fl-istudji dwar RCC (METEOR u CABOSUN)
English: In the 2-year rat carcinogenicity study, cabozantinibrelated neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
Maltese: Fl-istudju ta' sentejn dwar il-karċinoġeniċità fuq il-firien, sejbiet neoplastiċi relatati ma' cabozantinib kienu jikkonsistu f'inċidenza ogħla ta' feokromoċitoma beninni, waħedha jew f'kombinazzjoni ma' feokromoċitoma malinni/feokromoċitoma malinni komplessa tal-medulla adrenali fiżżewġ sessi f'esponimenti li huma inqas sew mill-esponiment intiż għall-bniedem.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
Maltese: Id-deċiżjoni biex it-terapija b'cabozantinib tissokta wara kirurġija għandha tkun ibbażata fuq ġudizzju kliniku ta' fejqan adegwat talferita.
English: Thirty-six percent (36%) of patients had bone metastases.
Maltese: Sitta u tletin fil-mija (36%) tal-pazjenti kellhom metastasi flgħadam.
English: EXP
Maltese: Xhur
English: Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Maltese: 37% Tul ta' żmien medjan ta' trattament b'sorafenib: 5.32 xhur
English: Fertility studies in rats have shown reduced male and female fertility.
Maltese: Studji dwar il-fertilità fil-firien urew fertilità mnaqqsa fl-irġiel u n-nisa.
English: Patients could have received other prior therapies, including cytokines, and antibodies targeting VEGF, the programmed death 1 (PD-1) receptor, or its ligands.
Maltese: Il-pazjenti setgħu kienu rċevew terapiji oħra minn qabel, inklużi ċitokini, u antikorpi li jimmiraw VEGF, ir-riċettur tal-mewt ipprogrammata 1 (PD-1 - programmed death 1), jew il-ligandi tiegħu.
English: The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Maltese: Il-livell bl-ebda effett avvers osservat (NOAEL - no observed adverse effect level) għal dawn is-sejbiet kien inqas mil-livelli ta' esponiment kliniku uman bid-doża terapewtika maħsuba.
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Maltese: Sejbiet fl-utru/ovarji u tnaqqis flematopoesi dehru li huma temporanji, filwaqt li l-effetti fuq il-parametri tal-għadam u l-pigmentazzjoni filfwied kienu sostnuti.
English: Hepatic encephalopathy
Maltese: IL-PRODOTT MEDIĊINALI
English: ATCvet code: QJ01MA90.
Maltese: Kodiċi ATCvet: QJ01MA90.
English: Bayer Hungária Kft. Alkotás u. 50
Maltese: L-Ungerija Bayer Hungária Kft. Alkotás u. 50
English: Bayer Limited Animal Health Division The Atrium
Maltese: L-Irlanda Bayer Limited Animal Health Division The Atrium
English: {Name and address} <{Tel.}> <{Fax}> <{E-mail}>
Maltese: {Isem u indirizz} <{Tel.}> <{Fax}> <{E-mail}>
English: Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona
Maltese: Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona
English: {Name and address} <{Tel}> <{Fax}> <{E-mail}>
Maltese: {Isem u indirizz} <{Tel}> <{Fax}> <{E-mail}>
English: Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA
Maltese: Ir-Renju Unit Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA
English: Terminal half-life (h) Elimination half-life (h) F (%)
Maltese: Half-life (h) ta' eliminazzjoni F (%)
English: I
Maltese: Ir
English: <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.>
Maltese: <Data tal-ewwel awtorizazzjoni:> <{DD/MM/YYYY}><{DD month YYYY}>
English: IV: Meat and offal: 5 days.
Maltese: IV: Laħam u interjuri: 5 ijiem.
English: Mommaertslaan 14 1831 Diegem (Machelen) Belgium
Maltese: Il-Belġju Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium
English: METHOD AND ROUTE(S) OF ADMINISTRATION IV, SC, IM
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI IV, SC, IM
English: 6.1 List of excipients n-Butyl alcohol
Maltese: 6.1 Lista ta' ingredjenti alkoħol n-Butyl
English: Mammals
Maltese: Mammiferi
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
Maltese: Antibatteriċi għal użu sistemiku, fluoroquinolones.
English: 30 mg. For the full list of excipients, see section 6.1.
Maltese: Għall-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: 7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
Maltese: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Maltese: Enrofloxacin huwa aġent kimoterapewtiku sintetiku mill-klassi tadderivati ta' fluoroquinolone carboxylic-acid.
English: Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany
Maltese: Il-Ġermanja Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany
English: On 26 October 2012, France sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Maltese: Fis-26 ta' Ottubru 2012, Franza bagħtet notifika ta' riferiment skont l-Artikolu 34(1) tadDirettiva 2001/82/KE, kif emendata, lis-CVMP/Aġenzija Ewropea għall-Mediċini għal Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom.
English: (e.g. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., against Gram-positive bacteria such as Staphylococcus spp.
Maltese: Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., kontra batterja pożittiva għal Gram bħal Staphylococcus spp.
English: Excipient: n-Butyl alcohol:
Maltese: alkoħol n-Butyl:
English: METHOD AND ROUTE(S) OF ADMINISTRATION SC, IM
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI SC, IM