FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder: Type I glass vial of either 5 ml or 23 ml with butyl rubber stopper sealed with an aluminium flip-off seal.
Maltese: Kunjett tal-ħġieġ ta' Tip 1 ta' 5 ml jew 23 ml b'tapp tal-butyl rubber b'siġill tl-aluminju flip-off.
English: Dogs:
Maltese: Dilwent:
English: Dog Cat
Maltese: U LUŻU
English: Following repeated administrations at the recommended dose, elevated concentrations of cefovecin were observed in plasma.
Maltese: Wara amministrazzjonijiet ripetuti tad-doża rrikmandata, ġew osservati konċentrazzjonijiet elevati ta'
English: Do not use in small herbivores (including guinea pigs and rabbits).
Maltese: Tużax f'erbivori żgħar (inkluż fniek tal-indi u fniek).
English: B. PACKAGE LEAFLET
Maltese: B'MOD KORRETT
English: (See also Section 12 ‘Special Warnings - For the animal'.)
Maltese: (Ara ukoll Sezzjoni 12 ‘Prekawzjonijiet Speċjali - Għall-annimal'.)
English: Each 10 ml vial of diluent contains:
Maltese: Kull kunjett ta' 10 ml dilwent fih:
English: field isolates.
Maltese: Klieb u qtates.
English: If an allergic reaction occurs, no further administrations of cefovecin should be administered and appropriate therapy for beta-lactam hypersensitivity should be instituted.
Maltese: Reżistenza inkroċjata tista' tidher ma' kefalosporini oħra u ma' antibijotiċi beta-lactam oħra.
English: Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young dogs.
Maltese: Ripetizzjoni tad-doża (tmin amministrazzjonijiet), ħames darbiet aktar minn dik irrikmandata f'intervalli ta' 14-il ġurnata, kienet ittollerata tajjeb fi qtates ta' età żghira.
English: The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Varuby contains the active substance rolapitant.
Maltese: Varuby fih is-sustanza attiva rolapitant.
English: Other information about Varuby
Maltese: Informazzjoni oħra dwar Varuby
English: The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors.
Maltese: Is-sustanza attiva f' Varuby, ir-rolapitant, taħdem billi timblokka r-riċetturi ta' neurokinina-1 (NK1).
English: Why is Varuby approved?
Maltese: Għaliex ġie approvat Varuby?
English: There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).
Maltese: Ma kienx hemm nawżja u remettar tardivi f' 71% tal-pazjenti li ngħataw Varuby (475 minn 666) meta mqabbla ma' 62% ta' dawk li ngħataw il-plaċebo (410 minn 666).
English: This is a summary of the European public assessment report (EPAR) for Varuby.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Varuby.
English: Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).
Maltese: Meta ntgħaddu r-riżultati taż-żewġ studji flimkien, ma kienx hemm nawżja u remettar fil-perjodu minn 24 sa 120 siegħa wara l-kimoterapija f' 71% talpazjenti (382 minn 535) li ngħataw Varuby, fil-waqt li ċ-ċifra bil-plaċebo kienet 60% (322 minn 535 pazjent).
English: What are the risks associated with Varuby?
Maltese: X' inhuma r-riskji assoċjati ma' Varuby?
English: In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist).
Maltese: Fiż-żewġ studji, fejn wieħed kien jinvolvi 532 pazjent u l-ieħor kien jinvolvi 555 pazjent, il-parteċipanti rċevew ukoll dexamethasone u granisetron (antagonista tar-riċettur 5-HT3).
English: The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache.
Maltese: L-effetti sekondarji l-aktar komuni b' Varuby (li jistgħu jaffettwaw bejn persuna 1 u 2 persuni minn kull 100) huma għeja u wġigħ ta' ras.
English: Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.
Maltese: Mediċini differenti tal-kimoterapija jipproduċu livelli differenti ta' nawżja u remettar, u Varuby jintuża f' pazjenti li jkunu qegħdin jirċievu kimoterapija emetoġenika (tikkaġuna remettar) għolja jew moderata.
English: Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.
Maltese: Varuby jingħata flimkien ma' dexamethasone u antagonista tar-riċettur 5-HT3 (żewġ tipi oħrajn ta' mediċini għall-prevenzjoni tan-nawżja u tar-remettar) iżda kif dawn jingħataw jiddependi mit-tip talkimoterapija.
English: Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer).
Maltese: Varuby huwa mediċina li tintuża għall-prevenzjoni ta' nawżja (tħossok ma tiflaħx) u remettar f' pazjenti adulti bil-kanċer li jkunu qegħdin jirċievu l-kimoterapija (mediċini għall-kura tal-kanċer).
English: Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy.
Maltese: Varuby kien ukoll iktar effettiv mill-plaċebo fit-tielet studju ewlieni meta ntuża ma' dexamethasone u granisetron f' pazjenti li ngħataw kimoterapija emetoġenika moderata.
English: Patients taking Varuby must not take St John's wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.
Maltese: Il-pazjenti li jieħdu Varuby m' għandhomx jieħdu il-fexfiex tarraba' (St John' s wort) (mediċina erbali għal dipressjoni ħafifa) peress li dan jista' jnaqqas l-effett ta' Varuby.
English: Varuby can only be obtained with a prescription and is available as 90-mg tablets.
Maltese: Varuby jista' jinkiseb biss b' riċetta ta' tabib u jiġi bħala pilloli ta' 90 mg.
English: Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting.
Maltese: Il-kimoterapija tista' tirrilaxxa sustanza fil-ġisem (sustanza P) li teħel ma' dawn ir-riċetturi u tistimula n-nawżja u r-remettar tardivi.
English: When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.
Maltese: Meta jingħata ma' mediċini li jaħdmu b' mekkaniżmi oħrajn għall-prevenzjoni tan-nawżja u tarremettar immedjati, Varuby jista' jgħin billi jipprovdi kontroll prolongat kontra dawn is-sintomi wara l-kimoterapija.
English: In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting.
Maltese: Barra minn hekk, kwalunkwe effett sekondarju kien maniġġabbli u kien simili għal dawk normalment osservati b' mediċini għan-nawżja u għar-remettar.
English: In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy.
Maltese: F' żewġ studji ewlenin, Varuby kien iktar effettiv mill-plaċebo (kura finta) fil-prevenzjoni tan-nawżja u tar-remettar tardivi wara kimoterapija emetoġenika għolja.
English: How does Varuby work?
Maltese: Kif jaħdem Varuby?
English: London, 14 July 2008 EMEA/CHMP/151554/2008
Maltese: Londra, 14 ta' Lulju 2008 EMEA/CHMP/151554/2008
English: Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendat.
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Pierre Demolis.
Maltese: IrRapportatur kien Dr Ian Hudson u l-Korapportatur kien Dr Pierre Demolis.
English: Repeat use: Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Maltese: Użu rrepetut: l-Awstrija, il-Bulgarija, Ċipru, Spanja, Franza, l-Italja, Malta u l-Portugall.
English: The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fil-15 ta' Novembru 2007 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: The Reference Member State was United Kingdom and the Concerned Member States were: First wave: Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden
Maltese: L-ewwel mewġa: il-Belġju, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, il-Ġermanja, ilGreċja, l-Ungerija, l-Iżlanda, l-Irlanda, il-Latvja, il-Litwanja, il-Lussemburgu, l-Olanda, in-Norveġja, ilPolonja, ir-Repubblika Slovakka, is-Slovenja u l-Iżvezja.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names International Non-Proprietary Name (INN): ciclesonide
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT TA' L-ARTIKOLU 29(4)1 GĦAL Alvesco u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): ciclesonide
English: The product contains ciclesonide which is delivered by a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as a propellant.
Maltese: Il-prodott fih ciclesonide li huwa fornut permezz ta' inalatur b'doża mkejla taħt pressjoni li fih ethanolic hydrofluoroalkane-134A bħala propellant.
English: Altana Pharma AG submitted applications for mutual recognition of Alvesco and associated names, 40µg, 80 µg and 160 µg pressurised inhalation, solution on the basis of the marketing authorisation granted by United Kingdom on 14 April 2004.
Maltese: Altana Pharma AG ssottomettiet applikazzjonijiet għal rikonoxximent reċiproku ta' Alvesco u ismijiet assoċjati, 40 µg, 80 µg u 160 µg soluzzjoni ta' inalazzjoni taħt pressjoni fuq il-bażi ta' l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mir-Renju Unit fl-14 ta' April 2004.
English: The Marketing Authorisation Holder provided written explanations on 16 January 2008.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ta spjegazzjonijiet bil-miktub fis-16 ta' Jannar 2008.
English: BACKGROUND INFORMATION
Maltese: III.
English: The Mutual Recognition Procedure started on 2 May 2007.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku nbdiet fit-2 ta' Mejju 2007.
English: During their March 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Alvesco and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Marzu 2008, is-CHMP, fid-dawl tad-dejta totali sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien ta' l-opinjoni li l-proporzjon benefiċċju/riskju kien favorevoli għal Alvesco u ismijiet assoċjati, li l-oġġezzjonijiet imqajmin minn Franza m'għandhomx jimpedixxu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, tikketta u fuljett ta'
English: Alvesco and associated names, 40 µg, 80 µg and 160 µg pressurised inhalation, solution is a glucocorticoid used to treat obstructive airway disease.
Maltese: Alvesco u ismijiet assoċjati, 40 µg, 80 µg u 160 µg soluzzjoni ta' inalazzjoni taħt pressjoni hija glukokortikojde wżata biex tittratta mard ostruttiv tal-passaġġi ta' l-arja.
English: In light of this, the applicant/MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Maltese: Fid-dawl ta' dan, l-applikant/MAH ippropona studju li jirrisolvi l-kwistjoni pendenti fuq l-użu fuq tul ta' żmien ta' 320 µg u 640 µg kuljum.
English: The United Kingdom referred the reasons of disagreement to the EMEA on 25 October 2007.
Maltese: Ir-Renju Unit irrefera r-raġunijiet għan-nuqqas ta' qbil lill-EMEA fil-25 ta' Ottubru 2007.
English: Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Maltese: Ġew identifikati differenzi sinjifikanti fir-rigward tal-pożoloġija approvata fil-preżent għall-kontroll ta' taħrixiet f'ażżma severa, u l-ħtieġa għal studju li jqabbel 160 µg, 320 µg u 640 µg/kuljum li juri tnaqqis filfrekwenza tat-taħrixiet f'pazjenti b'ażżma severa f'dożi ogħla.
English: In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/MAH has shown that a dose of 640µg/d (given 320µg/d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Maltese: B'mod partikolari, il-kitba proposta għal Sezzjoni 4.2 fi tmiem tal-proċedura CMDh kienet emendata biex tirrifletti li f'ażżmatiċi severi, studju ta' 12-il ġimgħa pprovdut mill-applikant/MAH wera li doża ta' 640µg/kuljum (mgħotija 320µg/kuljum darbtejn kuljum) uriet tnaqqis fil-frekwenza ta' taħrixiet iżda mingħajr titjib fil-funzjoni tal-pulmun.
English: The applicant/MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
Maltese: L-applikant/MAH aċċetta wkoll kitba aġġornata għal Sezzjoni 5.1, li tinkludi iktar dettall fuq Studju M1-140, fi tmiem il-proċedura CMDh, u Fuljett ta' Tagħrif aġġornat bis-sħiħ.
English: Additionally, the applicant/MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Maltese: Barra minn hekk, l-applikant/MAH kien mitlub li jimpenja ruħu li jikseb parir xjentifiku fir-rigward ta' lesplorazzjoni ta' disinn ta' studju addattat, u li jagħmel studju(i) bħal da(w)n biex jipprovdi iktar tagħrif dwar l-użu tad-doża ogħla ta' Alvesco fil-kontroll ta' ażżma severa.
English: The data supporting this application, as interpreted according with the CHMP guidance, did not support authorization of regular daily doses in excess of 160 µg in the treatment populations, and this was considered to be of serious public health concern.
Maltese: It-tagħrif li jappoġġja din l-applikazzjoni, kif interpretat b'mod konformi mal-gwida tas-CHMP, ma appoġġjax l-awtorizzazzjoni ta' dożi regolari ta' kuljum li jaqbżu 160 µg fil-popolazzjonijiet ikkurati, u dan kien ikkunsidrat li huwa ta' tħassib serju għas-saħħa pubblika.
English: Palazzo Volta - Via F. Sforza 20080 - Basiglio (Milano) Italia
Maltese: Palazzo Volta - Via F. Sforza 20080 - Basiglio (Milano) L-Italja
English: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Finland
Maltese: Il-Finlandja AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Finlandja
English: Testotoxicosis
Maltese: Testotoksikożi
English: Measured mean plasma concentrations were 44.4 (± 14.7) ng/ml and 165 (±90) ng/ml respectively.
Maltese: (+/- 14.7) ng/ml u 165 (+/-90) ng/ml rispettivament.
English: AstraZeneca GmbH 22876 Wedel
Maltese: Il-Germanja AstraZeneca GmbH 22876 Wedel
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi
Maltese: Theotokopoulou & Astronafton str 151 25
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
Maltese: NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussell
English: AstraZeneca Ősterreich GmbH Schwarzenbergplatz 7
Maltese: L-Awstrija AstraZeneca Ősterreich GmbH Schwarzenbergplatz 7
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem B-1180 Bruxelles
Maltese: Il-Lussemburgu NV AstraZeneca SA Rue Egide Van Ophem B-1180 Brussell
English: 1 place Renault 92844 Rueil-Malmaison Cedex
Maltese: Rueil-Malmaison Cedex
English: AstraZeneca AS Hoffsveien 70B, Box 200 Vinderen 0319 Oslo, Norway
Maltese: Box 200 Vinderen 0319 Oslo, In-Norveġja
English: AstraZeneca Pharmaceuticals AB S-15185 Södertälje Sweden
Maltese: Il-Bulgarija AstraZeneca Pharmaceuticals AB S-15185 Södertälje L-Isvezzja
English: Athens, Greece
Maltese: Athens, Il-Greċja
English: Paediatrics
Maltese: Pedjatrija
English: Short stature due to growth hormone deficiency A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11-16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Maltese: Statura żgħira minħabba nuqqas ta' l-ormon tat-tkabbir Studju randomised, double blind, multiċentriku evalwa 52 tifel fil-pubertà (bejn 11-16-il sena inklużi) fuq kura b'GHD li ngħataw kura għal 12 sa 36 xahar b'Arimidex 1 mg/jum jew plaċebo flimkien ma' l-ormon tat-tkabbir. 14-il individwu biss minn dawk li kienu fuq anastrozole temmew is-36 xahar.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Maltese: L-Aġenzija Ewropeja dwar il-Mediċini neħħiet l-obbligu li jiġu sottomessi r-riżultati ta' l-istudji b'Arimidex f'wieħed jew aktar sottogruppi tal-popolazzjoni pedjatrika ta' statura żgħira minħabba nuqqas ta' l-ormon tat-tkabbir (GHD), testotoksikożi, ġinekomastja u sindrome ta' McCune-Albright.
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Maltese: Ir-Rumanija AstraZeneca UK Limited 600 Capability Green
English: AstraZeneca A/S Roskildevej 22
Maltese: Id-Danimarka AstraZeneca A/S Roskildevej 22 2620 Albertslund
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9-week treatment-free recovery period.
Maltese: It-tnaqqis kien wieħed mumentanju peress li l-parametri dwar il-ħila ta' tgħammir u fertilità kienu simili mal-valuri millgruppi ta' kontroll wara perijodu ta' 9-ġimgħat mingħajr kura.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2-9) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Maltese: Studju open-label, mhux komparattiv evalwa 14-il pazjent maskili (bejn 2-9 snin) b'pubertà prekoċi assoċjata ma' l-irġiel tal-familja, magħrufa wkoll bħala testotoksikożi, ikkurata b'taħlita ta' Arimidex u bicalutamide.
English: After 3 years anastrozole was found to statistically significantly slow bone maturation in pubertal boys on growth hormone therapy.
Maltese: Wara 3 snin anastrozole instab li b'mod statistikament sinifikanti jikkawża ittardjar filmaturazzjoni ta' l-għadam f'subien waqt il-pubertà li jkunu fuq terapija bl-ormon tat-tkabbir.
English: AstraZeneca UK Limited, 15 Stanhope Gate, London W1K 1LN
Maltese: Stanhope Gate, London W1K 1LN
English: Children
Maltese: MEMBRI
English: Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Maltese: Arimidex mhux irrakkomandat għall-użu fit-tfal peress li m'hemmx biżżejjed informazzjoni dwar issigurtà u l-effikaċja (ara sezzjoni 4.4 u 5.1).
English: No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity.
Maltese: Ma kienx hemm differenza statistikament sinifikanti bil-plaċebo fil-parametri relatati mattkabbir fit-tul imbassar għal meta jsiru adulti, tul, tul SDS u kemm jitwalu malajr.
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Maltese: Fi studju dwar il-fertilità firien maskili li kienu għadhom kif waqfu mit-treddigħ kienu dożati b' 50 jew 400mg/l anastrozole mill-ħalq, permez ta' l-ilma tax-xorb tagħhom, għal 10 ġimgħat.
English: Velká Británie
Maltese: Velka Britanie
English: • Submit a Risk Management Plan (or its update) for Arimidex at National level, taking into account the new paediatric data and the CHMP recommendations.
Maltese: • Tissottometti Pjan ta' Ġestjoni tar-Riskju (jew aġġornament tiegħu) għal Arimidex fuq livell Nazzjonali, meħuda in konsiderazzjoni dejta pedjatrika ġdida u rakkommandazzjonijiet tasCHMP.
English: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.
Maltese: Capability Green, Luton, LU1 3LU, Ir-Renju Unit.
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Maltese: Fil-waqt li n-numru ta' tfal ikkurati kien limitat wisq sabiex jitfasslu konklużjonijiet affidabbli dwar is-sigurtà, kien hemm żieda fir-rata ta' fratturi u tendenza li tonqos id-densità minerali tal-għadam fil-fergħa ta' anastrozole imqabbla mal-plaċebo.
English: LU1 3LU, UK
Maltese: LU1 3LU, Ir-Renju Unit
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Maltese: Fil-prova klinika pivitali, ma deherx li kien effikaċi u s-sigurtà ma kienetx stabbilita (ara sezzjoni 5.1).
English: Arimidex is not indicated for use in children.
Maltese: Arimidex mhux indikat għall-użu fi tfal.
English: No data on the potential long-term effects of anastrozole treatment in children are available (see also section 5.3).
Maltese: M'hemmx dejta dwar l-effetti li jista' jkun hemm bil-kura fit-tul b'anastrazole fi tfal (ara wkoll sezzjoni 5.3).
English: Greece
Maltese: Greċja
English: SK 10 2 NA, UK
Maltese: SK 10 2 NA, Ir-Renju Unit
English: ANNEX II AMENDMENT TO SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: ANNESS II EMENDI FIS-SOMMARJU TAL-KARATTERISTIĊI
English: AstraZeneca UK Limited, Silk Road Business Park Macclesfield, Cheshire,
Maltese: AstraZeneca UK Limited, Silk Road Business Park Macclesfield,
English: Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level.
Maltese: L-indiċi tal-ħila biex jgħammru kienet imxekkla fiż-żewġ gruppi ta' kura, fil-waqt li tnaqqis fil-fertilità kienet evidenti biss bil-livell tad-doża b'400 mg/l.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT, ID-DETENTUR TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: AstraZeneca UK Limited 600 Capability Green Luton
Maltese: AstraZeneca UK Limited, 600
English: Since anastrozole reduces oestradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Maltese: Peress li anastrozole inaqqas il-livelli ta' oestradiol, Arimidex m'għandux jintuża fi bniet b'deffiċjenza fl-ormon tat-tkabbir flimkien mal-kura bl-ormon tat-tkabbir.
English: Czech Republic AstraZeneca UK Ltd Silk Road Business Park Macclesfield
Maltese: Il-Litwanja AstraZeneca UK Limited Silk Road Business Park Macclesfield
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek.
Maltese: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro u Valprolek.