FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to onset of the first diarrhoea event was approximately 6 to 8 days across studies, and the median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3) across studies.
Maltese: Il-medjan ta' żmien sal-bidu tal-ewwel avveniment tad-dijarea kien madwar 6 sa 8 ijiem fl-istudji kollha, u l-medjan tat-tul ta' żmien tad-dijarea kien minn 9 sa 12-il jum (Grad 2) u minn 6 sa 8 ijiem (Grad 3) fl-istudji kollha.
English: A risk to newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tattwelid/trabi mhux eskluż.
English: In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) and Cmax is approximately dose proportional.
Maltese: Fil-firxa tad-doża terapewtika ta' 50-200 mg, iż-żieda fl-esponiment fil-plażma (AUC) u s
English: However, cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males (see section 5.3).
Maltese: Madankollu, effetti ċitotossiċi lill-passaġġ riproduttiv tal-irġiel fil-firien u l-klieb jindika li abemaciclib jista' jindebolixxi l-fertilità fl-irġiel (ara sezzjoni 5.3).
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Maltese: Tel: + 39- 055 42571
English: [%] (95% CI) a Measurable disease defined per RECIST version 1.1 b Complete response + partial response c Complete response + partial response + stable disease for ≥ 6 months N=number of patients; CI=confidence interval; NR=not reached.
Maltese: b Rispons sħiħ + rispons parzjali c Rispons sħiħ + rispons parzjali + marda stabbli għal ≥ 6 xhur N= numru ta' pazjenti; CI=intervall ta' kunfidenza; NR=ma ntlaħaqx.
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Maltese: Infezzjonijiet jinkludu il-PTs kollha li jagħmlu parti mill-Klassi tas-Sistemi u tal-Organi
English: Verzenios 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Verzenios 50 mg
English: In patients who have had their dose reduced to 100 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose should be further reduced to 50 mg twice daily.
Maltese: F'pazjenti li tnaqqisitilhom id-doża għal 100 mg abemaciclib darbtejn kuljum u li għalihom ma jistax jiġi evitat l-għoti fl-istess waqt ta' inibitur qawwi ta' CYP3A4, id-doża ta' abemaciclib għandha tkompli titnaqqas għal 50 mg darbtejn kuljum.
English: Effects in lung and skeletal muscle occurred only in rats at exposure levels approximately 2-fold higher than human exposure levels and effects in kidney occurred only in rats at exposure levels approximately 6fold higher than human exposure levels.
Maltese: Effetti fuq il-pulmun u l-muskolu skeletriku seħħew biss fil-firien f'livelli ta' esponiment ta' madwar darbtejn aktar mill-livelli ta' esponiment fil-bniedem u effetti fil-kliewi seħħew biss fil-firien f'livelli ta'
English: Concentrations of abemaciclib and its active metabolites in cerebrospinal fluid are comparable to unbound plasma concentrations.
Maltese: Konċentrazzjonijiet ta' abemaciclib u l-metaboliti attivi tiegħu fil-fluwidu ċerebrospinali huma kumparabbli mal-konċentrazzjonijiet mhux marbuta fil-plażma.
English: Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy.
Maltese: Infezzjonijiet ġew irrappurtati f'pazjenti li kienu qed jirċievu terapija b'abemaciclib flimkien ma' terapija endokrinali b'rata akbar milli f'pazjenti ttrattati bi plaċebo flimkien ma' terapija endokrinali.
English: In healthy subjects, co-administration of abemaciclib and the P-glycoprotein (P-gp) substrate loperamide resulted in an increase in loperamide plasma exposure of 9% based on AUC0-∞ and 35% based on Cmax.
Maltese: F'individwi f'saħħithom, l-għoti ta' abemaciclib flimkien mas-sustrat tal-glikoproteina P (P-gp, P-glycoprotein) loperamide wassal għal żieda fl-esponiment ta' loperamide fil-plażma ta' 9% abbażi tal
English: • Periodic safety update reports
Maltese: Reviżjoni radjugrafika indipendenti,
English: Tiredness and dizziness are very common side effects.
Maltese: L-għeja u l-isturdament huma effetti sekondarji komuni ħafna.
English: The primary endpoint was investigator-assessed PFS evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Maltese: rata ta' benefiċċju kliniku (CBR, clinical benefit rate) u sopravivenza globali (OS, overall survival).
English: Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm.
Maltese: Tnaqqis fir riskju ta' progressjoni tal-marda jew mewt kien osservat f'pazjenti bil-marda fil-vixxri, (HR ta' 0.567 [95% CI: 0.407, 0.789]), medjan ta' PFS ta' 21.6 xhur versus 14.
English: Approximately 22% of patients had bone-only disease, and 53% patients had visceral metastases.
Maltese: Madwar 22% tal-pazjenti kellhom mard fl-għadam biss, u 53% tal-pazjenti kellhom metastasi fil-vixxri.
English: Grade 1 or 2
Maltese: Grad 1 jew 2
English: Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Maltese: Hija rrakomandata modifikazzjoni fid-doża għall-pazjenti li jiżviluppaw newtropenija ta' Grad 3 jew 4 (ara sezzjoni 4.2).
English: Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib.
Maltese: Verzenios 150 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 150 mg abemaciclib.
English: • Rash
Maltese: OĦRAJN
English: Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib.
Maltese: Verzenios 50 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 50 mg abemaciclib.
English: Developmental toxicity
Maltese: Tossiċità ta'
English: The primary target organ findings of potential relevance to humans included gastrointestinal and haematolymphopoietic organ effects in rats and dogs in studies up to 13 weeks duration.
Maltese: Is-sejbiet għall-organu l-aktar fil-mira ta' rilevanza possibbli għall-bniedem kienu jinkludu effetti fuq l organi gastrointestinali u ematolimfopoietiċi fil-firien u fil-klieb fi studji li damu sa 13-il ġimgħa.
English: 50 doses 125 doses
Maltese: 50 doża 125 doża
English: Zoetis Manufacturing & Research Spain, S.L.
Maltese: Zoetis Manufacturing & Research Spain, S.L. Ctra.
English: ATC Vet Code: QI09AA07
Maltese: QI09AA07.
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: 1348 Louvain-la-Neuve
English: Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014
Maltese: Data tal-aħħar tiġdid: 06/06/2014
English: Minimum Essential Medium without phenol red Sodium bicarbonate
Maltese: Minimum Essential Medium mingħajr phenol red Bikarbonat tas-sodjum
English: Lot {number}
Maltese: {numru}
English: These clinical signs normally resolve without treatment.
Maltese: Dawn is-sinjali kliniċi normalment jitilqu mingħajr trattament.
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 °C ).
English: CONTRAINDICATIONS
Maltese: KONTRA INDIKAZZJONIJIET
English: Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Maltese: Kaxxa tal-kartun ta' 10 fliexken ta' 10 dożi (20 ml), 50 doża (100ml) jew 125 doża (250 ml).
English: Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days.
Maltese: Reazzjonijiet lokali fit-tessut f'forma ta' nefħa fil-post ta' l-injezzjoni huma komuni ħafna u jistgħu jdumu sa 26 ġurnata.
English: Suvaxyn PCV suspension for injection for pigs
Maltese: VETERINARJU Suvaxyn PCV suspensjoni għall-injezzjoni għall-majjali
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: 0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Maltese: * L-unità tal-Qawwa Relattiva hija ddeterminata mill-kwantifikazzjoni ta' l-antiġen b'ELISA (test in vitro tal-qawwa) mqabbel ma' vaċċin ta' referenza.
English: One injection from 21 days of age.
Maltese: Skeda ta' tilqim: Injezzjoni waħda minn età ta' 21 ġurnata.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: USA
Maltese: UNITI
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Ċirkovirus tip 1 inattivat u rikombinanti tal-Majjali li għandu l-proteina ORF2 taċ-Ċirkovirus tip 2 tal majjali 1.6 ≤ RP ≤ 5.3
English: Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Maltese: Tilqim attiv tal-majjali b'età 'l fuq minn 3 ġimgħat kontra Ċirkovirus tip 2 tal-Majjali (PCV2) biex titnaqqas il-kwantità tal-virus fid-demm u fit-tessuti tal-limfa, u l-leżjonijiet fit-tessuti tal-limfa assoċjati ma' infezzjoni ta' PCV2, kif ukoll biex jitnaqqsu s-sinjali kliniċi - inkluż telf fiż-żjieda ta' piż ta' kuljum, u mortalità assoċjata mas-Sindrome ta' Post-Weaning Multisystemic Wasting (PMWS).
English: Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Maltese: Kaxxa ta' 10 fliexken ta' 10 dożi Kaxxa ta' 10 fliexken ta' 50 doża Kaxxa ta' 10 fliexken ta' 125 doża
English: It is intended to stimulate active immunity against PCV2 in piglets.
Maltese: Huwa maħsub biex jistimola immunità attiva kontra PCV2 fid- drafeċ.
English: Disposal: read the package leaflet.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Excipients:
Maltese: Inkompatibilitajiet:
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Onset of immunity: from 3 weeks post-vaccination.
Maltese: Bidu tal-immunità: minn 3 ġimgħat wara t-tilqima.
English: Name and address of the manufacturer of the biological active substance(s)
Maltese: Isem u indirizz tal-manufattur tas-sustanza bijoloġika attiva(i)
English: ROUTE(S) OF ADMINISTRATION
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu IM
English: Specific pharmacovigilance requirements:
Maltese: Grupp farmako-terapewtiku:
English: A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination.
Maltese: Waqt l-ewwel 24 siegħa wara t-tilqim, żieda temporanja fit-temperatura tal-ġisem (sa 1.7 °C) hija komuni ħafna.
English: Withdrawal period(s): Zero days.
Maltese: Żmien ta' tiżmim: 0 granet .
English: One dose of 2 ml contains:
Maltese: U KWANTITATTIVA Doża waħda ta' 2 ml fiha:
English: Per dose of 2 ml:
Maltese: (2 ml).
English: The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur.
Maltese: Il-firxa tar-reazzjonijiet lokali fit-tessut, ġeneralment hija ta' dijametru inqas minn 5 cm, iżda f'xi każijiet jista' jkun hemm nefħa akbar.
English: Intramuscular use
Maltese: TAL-PRODOTT MEDIĊINALI
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:
English: Ctra.
Maltese: Xejn.
English: Adjuvants:
Maltese: TAMMINISTRA
English: In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
Maltese: Fi studji kliniċi, awtopsja tal-post ta' linjezzjoni, li saret 8 ġimgħat wara l-għoti ta' doża waħda ta' vaċċin, uriet infjammazzjoni granulomatoża ħafifa sa moderata tal-fibri muskolari fil-post ta' l-injezzjoni.
English: Duration of immunity: 19 weeks post-vaccination.
Maltese: Tul ta' l-immunità: 19-il ġimgħa wara t-tilqima.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lillkirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma' l-ebda prodott mediċinali veterinarju ieħor.
English: 10 doses (20 ml)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 10 dożi (20 ml)
English: Pigs (piglets)
Maltese: INDIKAZZJONI(JIET)
English: To be supplied only on veterinary prescription.
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor.
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
Maltese: Ċirkovirus tip 1 inattivat u rikombinanti tal-Majjali li għandu l-proteina ORF2 taċ-Ċirkovirus tip 2 tal-majjali
English: Zero days.
Maltese: U LUŻU Ċ.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Maltese: Ħtiġijiet speċifiċi ta' farmakoviġilanza:
English: The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Maltese: L-istrejn tal-vaċċin hija Ċirkovirus tip 1 inattivat u rikombinanti tal-Majjali li għandu l-proteina ORF2 taċ-Ċirkovirus tip 2 tal-majjali.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Maltese: Sustanza(i) mhux attiva(i):
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.
Maltese: Immonoloġiċi għas-suidae, vaċċin virali inattivat.
English: Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-vaċċin jekk jintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - Mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: ADVERSE REACTIONS
Maltese: KARATTERISTIĊI
English: It contains the active substance dexrazoxane.
Maltese: Dan fih is-sustanza attiva dexrazoxane.
English: What is Cardioxane?
Maltese: X' inhu Cardioxane?
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Maltese: Riżultat ta' proċedura skont l-Artikolu 13 tar-Regolament (KE) Nru 1234/2008
English: What are the conclusions of the CHMP?
Maltese: X' inhuma l-konklużjonijiet tas-CHMP?
English: The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li t-tibdil jiġi rikonoxxut fir-Repubblika Ċeka, fil-Ġermanja, fi Franza, fl-Italja, fin-Netherlands, fil-Polonja, fi Spanja u fir-Renju Unit (l-"Istati Membri kkonċernati").
English: The company that markets the medicine is Clinigen Healthcare Limited.
Maltese: Il-kumpanija li tqiegħed il-mediċina fis-suq hija Clinigen Healthcare Limited.
English: On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection).
Maltese: Fit-18 ta' Mejju 2017, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ għal Cardioxane (dexrazoxane trab għal soluzzjoni għall-injezzjoni).
English: Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom.
Maltese: Cardioxane huwa awtorizzat fir-Repubblika Ċeka, fil-Ġermanja, fi Franza, fl-Italja, fin-Netherlands, filPolonja, fi Spanja u fir-Renju Unit.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Cardioxane on 19/07/2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti fl-UE kollha sabiex timplimenta rrakkomandazzjonijiet tas-CHMP dwar Cardioxane f' 19/07/2017.
English: Cardioxane is a medicine used in adults with breast cancer to prevent long-term harmful effects on the heart caused by treatment with the anthracycline cancer medicines doxorubicin and epirubicin.
Maltese: Cardioxane huwa mediċina li tintuża fl-adulti b' kanċer tas-sider biex tipprevjeni effetti ta' ħsara fit-tul fuq il-qalb li jiġu kkawżati mill-kura bil-mediċini tal-kanċer antraċiklini doxorubicin u epirubicin.
English: Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France.
Maltese: Cardioxane huwa awtorizzat bi proċedura ta' “rikonoxximent reċiproku”1 bbażata fuq awtorizzazzjoni inizjali mogħtija minn Franza.
English: In 2015, Clinigen submitted an application to the French medicines regulator ANSM for changes to the terms of the marketing authorisation, including removal of the contraindication in children and adolescents.
Maltese: Fl-2015, Clinigen ippreżentat applikazzjoni lir-regolatur tal-mediċini Franċiż ANSM għal tibdil fit-termini tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż it-tneħħija tal-kontraindikazzjoni fit-tfal u fladoloxxenti.
English: CHMP therefore concluded that the product information should state that the medicine is contraindicated in patients under 18 years old who are intended to receive a total cumulative dose of less than 300 mg of doxorubicin per m2 body surface or an equivalent dose of another anthracycline medicine.
Maltese: Għalhekk is-CHMP ikkonkluda li l-informazzjoni dwar il-prodott għandha tiddikjara li l-mediċina hija kontraindikata f' pazjenti taħt it-18-il sena li huma intiżi biex jirċievu doża kumulattiva totali ta' inqas minn 300 mg ta' doxorubicin għal kull m2 superfiċje tal-ġisem jew doża ekwivalenti ta' mediċina antraċiklina oħra.
English: However ANSM and the concerned Member States were unable to reach agreement on whether the contraindication could be removed just for children and adolescents treated with high cumulative doses of anthracyclines, and, on 31 January 2017, France referred the matter to the CHMP for arbitration.
Maltese: Madankollu ANSM u l-Istati Membri kkonċernati ma setgħux jilħqu qbil dwar jekk il-kontraindikazzjoni għandhiex titneħħa għat-tfal u għall-adoloxxenti kkurati b' dożi kumulattivi għoljin ta' antraċiklini biss, u, fil-31 ta' Jannar 2017, Franza rreferiet ilkwistjoni lis-CHMP għal arbitraġġ.
English: Because of concerns that it might increase the risk of second cancers developing long after treatment, the CHMP reviewed the medicine2 in September 2011 and recommended on the basis of the evidence at that time that use of medicines containing dexrazoxane to protect the heart should be explicitly contraindicated in children and adolescents.
Maltese: tal-evidenza ta' dak iż-żmien, irrakkomanda li l-użu tal-mediċini li fihom dexrazoxane biex jipproteġu lqalb għandhom jiġu kontraindikati b' mod espliċitu fit-tfal u fl-adoloxxenti.
English: The grounds for the referral were the concerns of the UK that removing the contraindication in patients less than 18 years old receiving a high cumulative dose of anthracyclines was not justified given the remaining uncertainties regarding the safety and effectiveness of Cardioxane in this population, particularly given the previous decision of the CHMP regarding dexrazoxane medicines.
Maltese: Ir-raġunijiet għar-riferiment kienu t-tħassib tar-Renju Unit li t-tneħħija tal-kontraindikazzjoni f' pazjenti iżgħar minn 18-il sena li jirċievu doża kumulattiva għolja ta' antraċiklini ma kinitx iġġustifikata minħabba l-inċertezzi li kien għad baqa' dwar is-sigurtà u l-effikaċja ta' Cardioxane f' din ilpopolazzjoni, b' mod partikolari minħabba d-deċiżjoni preċedenti tas-CHMP rigward il-mediċini b' dexrazoxane.
English: Based on evaluation of the currently available data, and the scientific discussion within the Committee, the CHMP concluded that the benefits and risks of Cardioxane have not been established in children under the age of 18 years, in whom it is not licensed, particularly given that most young patients do not receive the high total doses of anthracyclines that can cause damage to the heart.
Maltese: Abbażi tal-valutazzjoni tad-data disponibbli bħalissa, u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li l-benefiċċji u r-riskji ta' Cardioxane ma ġewx stabbiliti fi tfal taħt l-età ta' 18il sena, li mhuwiex liċenzjat għalihom, b' mod partikolari minħabba li l-biċċa l-kbira tal-pazjenti żgħar ma jirċivux d-dożi totali għoljin ta' antraċiklini li jistgħu jagħmlu ħsara lill-qalb.
English: 20 January 2012
Maltese: 20 ta' Jannar 2012
English: 1 Article 107 of Directive 2001/83/EC as amended.
Maltese: 1 L-Artikolu 107 tad-Direttiva 2001/83/KE kif emendata.
English: EMA/CHMP/382884 Rev. 1 EMEA/H/A-31/001261
Maltese: 1 EMEA/H/A-31/001261
English: What is nimesulide?
Maltese: X'inhu nimesulide?
English: • primary dysmenorrhoea (period pains).
Maltese: • dismenorrea primarja (uġigħ tal-period).
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Maltese: Nimesulide huwa mediċina anti-infjammatorja mhux sterojdi mhux selettiva (NSAID).