FrancophonIA/ELRC3.0 huggingface dataset:
English: At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea.
Maltese: Fil-bidu tat-terapija għandhom jiġu determinati l-frekwenza tal-ippurgar tal-pazjenti u kwalunkwe sintomu ieħor (eż. deni, brim, dardir, rimettar, sturdament u għatx), sabiex ikunu jistgħu jiġu identifikati bidliet waqt il-kura, kif ukoll biex tgħin jiġu identifikati pazjenti f'riskju akbar ta' dijarea.
English: The clinical significance of these effects on the pharmacokinetics of other medicinal products or the pharmacological activity of other anti-cancer medicinal products is not known.
Maltese: It-tifsira klinika ta' dawn l-effetti fuq il-farmakokinetika ta' prodotti mediċinali oħra jew l-attività farmakoloġika ta' prodotti mediċinali oħra kontra l-kanċer m'hix magħrufa.
English: Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal.
Maltese: Kien hemm tossiċità tal-fwied bl-użu ta' Tyverb u f'każi rari tista' tkun fatali.
English: The recommended dose of trastuzumab is 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/kg intravenous weekly (see section 5.1).
Maltese: Id-doża rakkomandata ta' trastuzumab hija 4 mg/kg mogħtija bħala doża tal-bidu (loading dose) filvini segwita minn 2 mg/kg fil-vini kull ġimgħa (ara sezzjoni 5.1).
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 (e.g. cisapride, pimozide and quinidine) should be avoided (see sections 4.4 and 5.2).
Maltese: (e.ż. cisapride, pimozide and quinidine) għandha tiġi evitata (ara sezzjonijiet 4.4 u 5.2).
English: Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Maltese: Id-dejta disponibbli f'pazjenti b'indeboliment epatiku hija nsuffiċjenti biex tipprovdi rakkommandazzjoni għal aġġustament tad-doża (ara sezzjoni 5.2).
English: • a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
Maltese: • reazzjoni fil-ġilda fil-paliet ta' l-idejn u s-saqajn (inkluż tingiż, tnemnim, uġigħ, nefħa jew ħmura)
English: Eligible patients were women with Stage IV ErbB2 gene amplified (or protein overexpressing) metastatic breast cancer who had been exposed to treatment with anthracyclines and taxanes.
Maltese: Il-pazjenti eliġibbli kienu nisa b'kanċer metastatiku tas-sider ta' Stadju IV amplifikat mill-ġene ErbB2 (jew espressjoni eċċessiva tal-proteini) li kienu ġew esposti għal kura b'anthracyclines u taxanes.
English: Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine.
Maltese: Hija disponibbli dejta dwar l-effikaċja u s-sigurtà ta' Tyverb mogħti flimkien ma' capecitabine meta mqabbla ma' trastuzumab mogħti flimkien ma' capecitabine.
English: These effects are described in section 4, ‘Possible side effects'.
Maltese: Dawn l-effetti huma deskritti f'sezzjoni 4 ‘Effetti sekondarji li jista' jkollu'.
English: Number of subjects who died Median overall survival, weeks Hazard Ratio (95% CI) p value
Maltese: Medja ta' sopravivenza fuq kollox, ġimgħat Proporzjon ta' periklu (95 % CI)
English: At the time of the final PFS analysis (with median follow-up of 2.64 years), the overall survival data were not mature and there was no significant difference between treatment groups in the HER2-positive population; this had not changed with additional follow-up (>7.5 years median followup time; Table 7).
Maltese: Fi żmien l-analiżi tal-PFS finali (b'segwitu medju ta' 2.64 snin), id-dejta tas-sopravivenza globali ma kienetx matura u ma kien hemm l-ebda differenza sinifikanti bejn il-gruppi ta' kura fil-popolazzjoni HER2-pożittiv; dan ma kienx inbidel f'segwitu addizzjonali (b'segwitu medju ta' > 7.5 snin; Tabella 7).
English: Results of an updated analysis of the overall survival data to 28 September 2007 are presented in Table 2.
Maltese: Riżultati ta'analiżi aġġornata tad-dejta dwar sopravivenza totali sat-28 ta' Settembru 2007 qed jiġu preżentati f'Tabella 2.
English: Cardiac electrophysiology
Maltese: Tossiċità fil-fwied
English: If the toxicity recurs, then Tyverb should be restarted at a lower dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor).
Maltese: Jekk it-tossiċità terġa' titfaċċa, Tyverb imbagħad għandu jinbeda b'doża aktar baxxa (750 mg/ġurnata meta jingħata ma' trastuzumab,1000 mg/ġurnata meta mogħti ma' capecitabine jew 1250 mg/ġurnata meta mogħti ma' inibitur ta' aromatase).
English: Tyverb should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Maltese: Tyverb m'għandux jibqa' jingħata lill-pazjenti li jesperjenzaw sintomi pulmonarji li huma ta' NCI CTCAE grad 3 jew aktar (ara sezzjoni 4.4).
English: Subjects who had received prior trastuzumab* N
Maltese: • tħossok imdardar/imdardra (nawsja)
English: No overall differences in efficacy and safety of the combination of Tyverb and letrozole were observed between these patients and patients < 65 years of age.
Maltese: Ma kienet osservata l-ebda differenza globali fl-effikaċja u fissigurtà tat-taħlita ta' Tyverb u letrozole bejn dawn il-pazjenti u pazjenti b'età < 65 sena.
English: A concentration-dependent increase of the QTc interval was demonstrated in a dedicated placebo-controlled crossover study in subjects with advanced solid tumours.
Maltese: Fi studju crossover, dedikat, ikkontrollat bi plaċebo f'individwi b'tumuri solidi avanzati ntweriet żieda dipendenti mill-konċentrazzjoni fl-intervall QTc.
English: Hepatotoxicity
Maltese: • stitikezza
English: HER2-overexpressing population HER2-negative population N = 111
Maltese: Popolazzjoni negattiva għallHER2
English: Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before the initiation of treatment and monthly thereafter, or as clinically indicated.
Maltese: Għandu jkun osservat il-funzjoni tal-fwied (transaminases, bilirubin u alkaline phosphatase) qabel tibda' l-kura u kull xahar wara, jew kif indikat klinikament.
English: Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with Tyverb.
Maltese: Il-meraq tal-grejpfrut jista' jimpedixxi CYP3A4 fil-membrana tal-musrana u jżid il-biodisponibiltà ta' lapatinib u għalhekk għandu jiġi evitat waqt kura b'Tyverb.
English: Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG' marked on one side.
Maltese: Il-pilloli miksija b'rita Tyverb huma ovali, konvessi fuq iż-żewġ naħat, sofor miksijin b'rita b'‘GS XJG' immarkata fuq naħa waħda.
English: Tyverb has been studied in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive (oestrogen receptor [ER] positive and / or progesterone receptor [PgR] positive) advanced or metastatic breast cancer.
Maltese: Tyverb kien studjat flimkien ma' letrozole għall-kura ta' nisa wara l-menopawsa b'kanċer avanzat jew metastatiku tas-sider pożittiv għar-riċettur ta' l-ormon (pożittiv għar-riċettur ta' l-estroġenu [ER] u / jew pożittiv għar-riċettur tal-proġesteron [PgR]).
English: Co-administration of Tyverb with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
Maltese: L-amministrazzjoni ta' Tyverb flimkien ma' impedituri moderati ta' CYP3A4 għandha ssir b'attenzjoni u għandu jkun hemm monitoraġġ b'attenzjoni għal reazzjonijiet kliniċi avversi.
English: Evaluation of cardiac function, including LVEF determination, should be conducted for all patients prior to initiation of treatment with Tyverb to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
Maltese: Għandu jsir evalwazzjoni tal-funzjoni tal-qalb, inkluż determinazzjoni ta' LVEF għall-pazjenti kollha qabel ma' tinbeda l-kura b'Tyverb biex ikun żgurat li l-pazjent għandu linja bażi ta' LVEF li qegħda fil-limiti tan-normal ta' l-istituzzjoni.
English: Caution is warranted if Tyverb is prescribed to patients with moderate or severe hepatic impairment and to patients with severe renal impairment (see sections 4.2 and 5.2).
Maltese: Hija meħtieġa attenzjoni jekk Tyverb jiġi preskritt lill-pazjenti b'indeboliment epatiku moderat jew serju u lill-pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.2 u 5.2).
English: Tyverb dosing should be permanently discontinued in patients with diarrhoea which is NCI CTCAE grade 4.
Maltese: Żieda fl-inċidenza u l-qawwa ta' dijarea u newtropenija kienet osservata b'din it-taħlita fi studji kliniċi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14.11.2007
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 14.11.2007
English: Hampshire RG24 9NL United Kingdom
Maltese: Hampshire RG24 9NL Ir-Renju Unit
English: PHARMACEUTICAL FORM Oral suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni orali.
English: CONTRAINDICATIONS
Maltese: KONTRA-INDIKAZZJONIJIET
English: A clinical response is normally seen within 3 - 4 days.
Maltese: Rispons kliniku ġeneralment ikun osservat fi żmien 3 - 4 ijiem.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu mediċina mhux sterojdi u anti-infjammatorja (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, anti-exudative, u antipiretiċi.
English: Marketing authorisation holder: Eli Lilly and Company Limited Elanco Animal Health Lilly House, Priestley Road Basingstoke
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ: Eli Lilly and Company Limited Elanco Animal Health Lilly House, Priestley Road Basingstoke
English: PHARMACEUTICAL FORM Oral suspension
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni orali
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Maltese: Studji in vivo u in vitro urew li meloxicam jinibixxi cyclooxygenase-2 (COX-2) b'mod iktar qawwi minn cyclooxygenase-1 (COX-1).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 1.5 mg/ml
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Meloxicam 1.5 mg/ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 0.5 mg/ml
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI Meloxicam 0.5 mg/ml
English: Microcrystalline cellulose Xxanthan gum Carboxymethylcellulose Sodium benzoate Sodium saccharinate
Maltese: 6.1 Lista ta' ingredjenti microcrystalline cellulose xanthan gum carboxymethylcellulose sodium benzoate sodium saccharinate glycerol sorbitol citric acid monohydrate sodium hydroxide ilma ppurifikat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Maltese: U KWANTITATTIVA Millilitru fih:
English: The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight).
Maltese: Is-siringa taqbel mal-flixkun u għandha skala ta' kg-piż tal-ġisem li tikkorrispondi għad-doża tal-manteniment (i.e. 0.1 mg ta' meloxicam/kg ta' piż tal-ġisem).
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams), ATCvet code: QM01AC06
Maltese: Prodotti anti-infammatorji u anti-rewmatiċi, Mhux sterojdi (oxicams).
English: PACKAGE SIZE 150 ml
Maltese: DAQS TAL-PAKKETT 150 ml
English: INDICATION(S) Acute and chronic musculo-skeletal disorders.
Maltese: INDIKAZZJONI(JIET) Disturbi muskolu-skeletriċi akuti u kroniċi
English: In very rare cases haemorrhagic diarrhoea, haematemisis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Maltese: F'każijiet rari ħafna dijarea emorraġika, ematemesi, ulċerazzjoni gastrointestinali u livelli għolja ta' enzimi tal-fwied ġew irrappurtati.
English: Date of last renewal:
Maltese: Data ta' l-aħħar tiġdid:
English: 1 mg For a full list of excipients, see section 6.1.
Maltese: 1 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for bottle 10, 30 and 150 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun għal flixkun ta' 10, 30 u 150 ml
English: Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Maltese: Tużax fuq klieb li jkunu jbatu minn disturbi gastrointestinali, bħal irritazzjoni u emorraġija, indeboliment fil-funzjoni epatika, kardijaka jew renali u disturbi emorraġiċi.
English: The suspension has to be given with the measuring syringes provided in the package of the 30 ml and 150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack size.
Maltese: Is-suspensjoni għandha tingħata permezz tas-siringa tal-kejl ipprovduta fil-pakketti ta' 30 ml u ta' 150 ml jew permezz ta' waħda miż-żewġ siringi tal-kejl ipprovduti fil-pakketti ta' 10 ml.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Treatment is to be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Maltese: Il-kura għandha titkompla darba kuljum bl-għoti orali (f'intervalli ta' 24 siegħa) bid-doża tal-manteniment ta' 0.1 mg ta' meloxicam/kg ta' piż tal-ġisem.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxivet 0.5 mg/ml oral suspension for dogs
Maltese: VETERINARJU Meloxivet 0.5 mg/ml suspensjoni orali għall-klieb
English: Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 6.1 hours.
Maltese: Meloxicam huwa kompletament assorbit wara l-għoti orali u l-ogħla konċentrazzjonijiet fil-plażma jinkisbu wara madwar 6.1 sigħat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxivet 1.5 mg/ml oral suspension for dogs
Maltese: VETERINARJU Meloxivet 1.5 mg/ml suspensjoni orali għall-klieb
English: PACKAGE LEAFLET FOR: Meloxivet 0.5 mg/ml oral suspension for dogs
Maltese: FIL-PAKKETT GĦAL: Meloxivet 0.5 mg/ml suspensjoni orali għall-klieb
English: Approximately 75 % of the administered dose of meloxicam is eliminated via faeces and the remainder via urine.
Maltese: Madwar 75% tad-doża ta' Meloxicam li tingħata titneħħa fl-ippurgar, u l-bqija fl-awrina.
English: There is a linear relationship between the dose of meloxicam administered and plasma concentration observed in the therapeutic dose range.
Maltese: Hemm relazzjoni lineari bejn id-doża ta' meloxicam mogħtija u l-konċentrazzjoni fil-plażma osservata fil-firxa tad-doża terapewtika.
English: Microcrystalline cellulose Xanthan gum Carboxymethylcellulose Sodium benzoate Sodium saccharinate Glycerol
Maltese: Waħħal issiringa tad-dożaġġ mal-flixkun billi timbotta bil-mod ittarf tagħha fuq innaħa ta' fuq talflixkun
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġietx stabbilita waqt it-tqala u fi żmien il-ħalib (ara sezzjoni 4.3).
English: SPECIAL WARNING(S)
Maltese: ATTIVA(I)
English: EXPIRY DATE EXP
Maltese: HUWA INDIKAT IL-PRODOTT
English: Glycerol
Maltese: TWISSIJIET SPEĊJALI
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Jekk jogħġbok segwi blattenzjoni l-istruzzjonijiet tal-veterinarju.
English: 30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
Maltese: Preżentazzjoni ta' 30 ml u 150 ml: flixkun tal-ħġieġ ta' lewn safrani (tip III) b'għatu tal-polypropylene li jirreżisti l-ftuħ mit-tfal, insert tal-polyethylene u siringa tad-dożaġġ tal-polypropylene ta' lewn ċar.
English: Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' NSAIDs bħal nuqqas ta' aptit, rimettar, dijarea, demm moħbi flippurgar, letarġija u insuffiċjenza tal-kliewi ġew irrappurtati xi kultant.
English: White to yellowish opaque suspension.
Maltese: Suspensjoni opaka minn bajda sa safranija.
English: People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li hu magħruf li għandhom sensittività eċċessiva għal mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for bottle 10 and 30 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun għal flixkun ta' 10 u 30 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/077/003
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/07/077/003
English: The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).
Maltese: Is-suspensjoni tal-pakketti ta' 10 ml tista' tingħata permezz tal-iżgħar siringa f'każ ta' klieb li l-piż talġisem tagħhom huwa anqas minn 8 kg (marka waħda fuq il-flixkun tikkorrispondi għal 0.5 kg ta' piż tal-ġisem) jew permezz tal-akbar siringa f'każ ta' klieb li l-piż tal-ġisem tagħhom huwa aktar minn 8 kg (marka waħda fuq il-flixkun tikkorrispondi għal 2.0 kg ta' piż tal-ġisem).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/077/001
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/07/077/001
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/077/005
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/07/077/005
English: 30 ml: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
Maltese: 30 ml: flixkun tal-ħġieġ ta' lewn safrani (tip III) b'għatu tal-polypropylene li jirreżisti l-ftuħ mit-tfal, insert tal-polyethylene u siringa tad-dożaġġ tal-polypropylene ta' lewn safrani.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) INGREDJENT(I) OĦRA Millilitru fih:
English: 10 ml: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
Maltese: 10 ml: flixkun tal-ħġieġ ta' lewn safrani (tip III) b'għatu tal-polyethylene li jirreżisti l-ftuħ mit-tfal, insert tal-polyethylene u siringa tad-dożaġġ tal-polypropylene ta' lewn safrani.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: 10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and an amber polypropylenedosing syringe.
Maltese: Preżentazzjoni ta' 10 ml: flixkun tal-ħġieġ ta' lewn safrani (tip III) b'għatu tal-polyethylene li jirreżisti l-ftuħ mit-tfal, insert tal-polyethylene u siringa tad-dożaġġ tal-polypropylene ta' lewn ċar.
English: It reduces leukocyte infiltration into the inflamed tissue.
Maltese: Meloxicam inaqqas l-infiltrazzjoni tal-lewkoċiti fit-tessut infjammat.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ: 3 snin.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of renal toxicity.
Maltese: Evita l-użu fi kwalunkwe kelb li jkun deidrat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta' żieda tat-tossiċità renali.
English: Manufacturer for the batch release:
Maltese: Sustanza mhux attiva:
English: The suspension has to be given with the measuring syringe provided in the package.
Maltese: Is-suspensjoni għandha tingħata permezz tas-siringa tal-kejl ipprovduta fil-pakkett.
English: PACKAGE LEAFLET FOR: Meloxivet 1.5 mg/ml oral suspension for dogs
Maltese: Meloxivet 1.5 mg/ml suspensjoni orali għall-klieb
English: ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: MOD TA' AMMINISTRAZZJONI Użu orali.
English: 30 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and an amber polypropylene dosing syringe.
Maltese: Preżentazzjoni ta' 30 ml: flixkun tal-ħġieġ ta' lewn safrani (tip III) b'għatu tal-polypropylene li jirreżisti l-ftuħ mit-tfal, insert tal-polyethylene u siringa tad-dożaġġ tal-polypropylene ta' lewn safrani.
English: Particular care should be taken with regard to the accuracy of dosing.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu jitpoġġew fis-suq.
English: London, 22 November 2007 EMEA/433691/2007
Maltese: Londra, 22 ta' Novembru 2007 EMEA/433691/2007
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: 1 Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendata.
English: The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher.
Maltese: IrRapporteur kien Dr Ondrej Slanar u l-Ko-Rapporteur kien Dr Matthew Thatcher.
English: The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom.
Maltese: L-Istat Membru ta' Referenza kienu r-Repubblika Ċeka u l-Istati Membri Ikkunċernati kienu l-Awstrija, id-Danimarka, il-Ġermanja, l-Estonja, il-Greċja, Franza, l-Ungerija, l-Italja, ilLatvja, il-Litwanja, l-Olanda, in-Norverġja, il-Polonja, il-Portugall, l-Iżvezja, l-Islovenja, ir-Reppublika Slovakka u r-Renju Unit.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI SKOND L-ARTIKOLU 29(4)1 REFERENZA GĦAL Bicaluplex u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (INN- Internatinal Non-proprietary Name ): bicalutimade
English: Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.
Maltese: Bicaluplex u ismijiet assoċjati; pillola ta' 150 mg miksija b'rita, hija anti-androġenu orali wżata fil-kura talkanċer tal-prostata.
English: Ingers Industrials Solutions s.r.o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005.
Maltese: Ingers Industrials Solutions s.r.o daħħal applikazzjonijiet għar-rikonnoxximent reċiproku ta' Bicaluplex u ismijiet assoċjati, pillola ta' 150mg miksija b'rita, abbażi ta' l-awtorizzazzjonijiet għat-tqegħid fis-suq mogħtija mir-repubblika Ċeka fit-30 ta' Novembru 2005.