FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Maltese: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: Memantine Accord 15 mg film-coated tablets are presented as orange to grey-orange, oblong, coated tablet, debossed with “MT” on one side and “15” on the other side.
Maltese: Il-pilloli miksija b'rita ta' 15 mg ta' Memantine Accord jiġu bħala pilloli oranġjo għal oranġjo griżi, f'għamla tawwalija, imnaqqxa bl-ittri “MT” fuq naħa u “15” fuq in-naħa l-oħra.
English: Memantine Accord 20 mg film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “20” divided by the score on the other side.
Maltese: Il-pilloli miksija b'rita ta' 20 mg huma pilloli ħomor ċari għal ħomor griżi, tawwalin, immarkati u miksija, imnaqqxa bl-ittri “MT”, maqsuma biċ-ċifra fuq naħa u “20” maqsuma miċ-ċifra fuq in-naħa loħra.
English: • Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi talbilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini.
English: Some factors that may raise urine pH (see section 5.2 'Elimination') may necessitate careful monitoring of the patient.
Maltese: Xi fatturi li jistgħu jgħollu l-pH tal-awrina (ara sezzjoni 5.2 “Eliminazzjoni”) jistgħu jeħtieġu monitoraġġ bir-reqqa tal-pazjent.
English: NAME OF THE MEDICINAL PRODUCT Memantine Accord 20 mg film-coated tablets memantine hydrochloride
Maltese: TAL-PRODOTT MEDIĊINALI Memantine Accord 20 mg pilloli miksijin b'rita memantine hydrochloride
English: Memantine Accord contains lactose.
Maltese: Memantine Accord fih il-lattożju.
English: Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Maltese: Ġimgħa 2 (jum 8-14) Ħu pillola miksija b'rita waħda ta' 10 mg kuljum (bajda, immarkata) għal 7 t'ijiem.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-websajt tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: EU/1/13/880/009 28 fim-coated tablets EU/1/13/880/010 42 fim-coated tablets EU/1/13/880/011 56 fim-coated tablets EU/1/13/880/012 98 fim-coated tablets EU/1/13/880/015 14 fim-coated tablets
Maltese: EU/1/13/880/009 28 pillola miksija b'rita EU/1/13/880/010 42 pillola miksija b'rita EU/1/13/880/011 56 pillola miksija b'rita EU/1/13/880/012 98 pillola miksija b'rita EU/1/13/880/015 14 pillola miksija b'rita
English: The 5 mg film-coated tablets are white, oblong, coated tablets, debossed with "MT" on one side and "5" on the other side.
Maltese: Il-pilloli miksija b'rita ta' 5 mg ta' Memantine Accord jiġu bħala pilloli bojod, f'għamla tawwalija u miksija, imnaqqxa bl-ittri “MT” fuq naħa waħda u b'“5” fuq in-naħa l-oħra.
English: The 15 mg film-coated tablets are orange to grey-orange, oblong, coated tablets debossedwith "MT" on one side and "15" on the other side.
Maltese: Il-pilloli miksija b'rita ta' 15 mg huma oranġjo għal oranġjo griżi, pilloli miksija b'rita li huma oblong, imnaqqxa bl-ittri “MT” fuq naħa u “15” fuq naħa oħra.
English: Memantine Accord 10 mg film-coated tablets are presented as white, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “10” divided by the score on the other side.
Maltese: Il-pilloli miksija b'rita ta' 10 mg ta' Memantine Accord jiġu bħala pilloli miksija u mmarkati bojod, f'għamla tawwalija, imaqqxa bl-ittri “MT”, maqsuma biċ-ċifra fuq naħa u “10” maqsuma biċ-ċifra fuq in-naħa l-oħra.
English: • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Maltese: • Il-mod kif jaħdem jindika li l-effeti tal-Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma' antaginisti ta' NMDA bħal memantine.
English: Tablet cores for 5/10/15/20 mg film-coated tablets Lactose monohydrate
Maltese: Kull pillola miksija b'rita fiha 5/10/15/20 mg memantine hydrochloride li hi ekwivalenti għal 4.15/8.31/12.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Maltese: Minbarra hekk, il-pH tal-awrina tista' titla minħabba każijiet ta' aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal-passaġġ awrinarju b'Proteus bacteria.
English: Pack sizes of 14, 28, 30, 42, 50, 56, 98, 100 and 112 tablets are presented.
Maltese: Folja tal-aluminju-PVC/PE/PVDC Il-pakketti jiġu f'daqsijiet ta' 14, 28, 30, 42, 50, 56, 98, 100 u 112-il pillola.
English: Biotransformation:
Maltese: Distribuzzjoni:
English: Treatment initiation pack
Maltese: TAL-PRODOTT MEDIĊINALI
English: NAME OF THE MEDICINAL PRODUCT Memantine Accord 10 mg film-coated tablets memantine hydrochloride
Maltese: TAL-PRODOTT MEDIĊINALI Memantine Accord 10 mg pilloli miksijin b'rita memantine hydrochloride
English: • Inflammation of the pancreas, inflammation of the liver and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Maltese: • Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied u reazzjonijiet psikotiċi Il-marda ta' Alzheimer kienet assoċjata ma' dipressjoni, ħsibijiet ta' suwiċidju u suwiċidju.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Maltese: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa ħaj meta ħa b'mod orali 2,000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal 10 t'ijiem, u wara kellu diplopja u aġitazzjoni).
English: Film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Maltese: Pilloli miksijin b'rita 14 pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita
English: EU/1/13/880/001 EU/1/13/880/002 EU/1/13/880/003 EU/1/13/880/004 EU/1/13/880/005 EU/1/13/880/006 EU/1/13/880/007 EU/1/13/880/008 EU/1/13/880/014 EU/1/13/880/016 EU/1/13/880/017 EU/1/13/880/018 EU/1/13/880/019
Maltese: EU/1/13/880/005 EU/1/13/880/006 EU/1/13/880/007 EU/1/13/880/008
English: Memantine Accord 5 mg film-coated tablets Memantine Accord 10 mg film-coated tablets Memantine Accord 15 mg film-coated tablets Memantine Accord 20 mg film-coated tablets
Maltese: Memantine Accord 5 mg pilloli miksijin b'rita Memantine Accord 10 mg pilloli miksijin b'rita Memantine Accord 15 mg pilloli miksijin b'rita Memantine Accord 20 mg pilloli miksijin b'rita
English: Uncommon Fatigue
Maltese: Mhux komuni
English: Memantine Accord 20 mg film-coated tablets
Maltese: Memantine Accord 20 mg pilloli miksija b'rita.
English: Memantine Accord contains lactose
Maltese: Memantine Accord fih il-lattożju
English: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine - The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172) all in the tablet coating
Maltese: polysorbate 80, macrogol 400, titanium dioxide (E 171), iron oxide aħmar (E 172), iron oxide isfar (E 172), li lkoll jinsabu fil-kisja tal-pilloli.
English: Crospovidone
Maltese: Ċipru
English: Pack sizes of 14, 28, 42, 56 and 98 tablets are presented.
Maltese: Folji tal-aluminju PVC/PE/PVDC Daqsijiet tal-pakkett ta' 14, 28, 42, 56 u 98 pillola miksija b'rita huma disponibbli.
English: Tablet coat for 5/10/15/20 mg film-coated tablets
Maltese: Il-kisja tal-pilloli miksija b'rita ta' 5/1015/20 mg
English: White, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and "10" divided by the score on the other side.
Maltese: Pillola bajda, tawwalija, miksija u mmarkata, imnaqqxa bl-ittri “MT” maqsumin bejniethom bil-qasma fuq naħa waħda u biċ-ċifri “10” maqsumin bil-qasma fuq in-naħa l-oħra.
English: one and a half 10 mg tablet week 4 and beyond two 10 mg tablets once a day
Maltese: pillola u nofs ta' 10mg minn ġimgħa 4 'l quddiem żewġ pilloli ta' 10 mg darba kuljum
English: None of these metabolites exhibit NMDA-antagonistic activity.
Maltese: L-ebdawieħed minn dawn il-metaboli m'għandu attività antagonista għal NMDA.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli ta' CSF qablu mal-valur-ki (ki = kostanti talimpediment) ta' memantine, li hija 0.5 µmol fil-kortiċi ta' quddiem tal-bniedem.
English: The full EPAR for Docetaxel Kabi 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: Docetaxel Kabi docetaxel
Maltese: Docetaxel Kabi doketaksel
English: Docetaxel Kabi is a ‘generic medicine'.
Maltese: Docetaxel Kabi huwa ‘mediċina ġenerika'.
English: Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docetaxel Kabi jintuża malprednisonu jew mal-prednisolonu (mediċini anti-infjammatorji);
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Kabi.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Docetaxel Kabi.
English: Docetaxel Kabi is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Kabi huwa mediċina li fiha s-sustanza attiva doketaksel.
English: Docetaxel Kabi is used with cisplatin and 5-fluorouracil.
Maltese: Docetaxel Kabi jintuża maċ-ċisplatinu u mal-5-fluorouraċile.
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Kabi has been shown to be comparable to Taxotere.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, intwera li Docetaxel Kabi jista' jitqabbel ma' Taxotere.
English: Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Maltese: Docetaxel Kabi jintuża maċ-ċisplatinu u mal-5-fluorouraċile (mediċini oħra kontra l-kanċer);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Kabi on 22 May 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ipreziv f'22 ta' Mejju 2012.
English: • breast cancer.
Maltese: • kanċer fiċ-ċelloli mhux żgħar fil-pulmun.
English: The company provided data from published literature on docetaxel.
Maltese: Il-kumpanija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar id-doketaksel.
English: This means that Docetaxel Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: Dan ifisser li Docetaxel Kabi huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Taxotere.
English: Docetaxel Kabi is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: Docetaxel Kabi jintuża biss meta l-għadd tan-newtrofili (tip ta' ċelloli bojod fid-demm) ikun normali (tal-inqas 1,500 ċellola/mm3).
English: The active substance in Docetaxel Kabi, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Kabi, id-doketaksel, tappartieni lill-grupp ta' mediċini kontra l-kanċer magħrufa bħala tassini.
English: Docetaxel Kabi should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Docetaxel Kabi għandu jintuża fis-swali tal-kura speċjalizzati fl-għoti ta' kemjoterapija (l-użu ta' mediċini għall-kura tal-kanċer) taħt is-superviżjoni ta' tabib ikkwalifikat fl-għoti ta' kemjoterapija.
English: No additional studies were needed as Docetaxel Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Ma kien jenħtieġ isir l-ebda studju addizzjonali peress li Docetaxel Kabi huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fiha l-istess sustanza attiva tal-mediċina ta' referenza, Taxotere.
English: What are the benefits and risks of Docetaxel Kabi?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Docetaxel Kabi?
English: What is Docetaxel Kabi?
Maltese: X'inhu Docetaxel Kabi?
English: Why has Docetaxel Kabi been approved?
Maltese: Għaliex ġie approvat Docetaxel Kabi?
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Taxotere, il-benefiċċju huwa akbar mir-riskju identifikati.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Maltese: • adenokarċinoma gastrika (tip ta' kanċer fl-istonku) fuq pazjenti li ma jkun għadhom irċevew l-ebda trattament għall-kanċer tagħhom.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll maċ-ċisplatinu (mediċina oħra kontra l-kanċer) fuq pazjenti li ma jkun għadhom ingħataw l-ebda trattament għall-kanċer tagħhom;
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion.
Maltese: Lill-pazjent għandha tingħatalu wkoll mediċina anti-infjammatorja, bħad-deksametasonu, fil-jum ta' qabel l-infużjoni b'Docetaxel Kabi.
English: Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Docetaxel Kabi huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Maltese: • kanċer fil-prostata, meta l-kanċer ma jirrispondix għall-kura bl-ormoni.
English: How has Docetaxel Kabi been studied?
Maltese: Kif ġie studjat Docetaxel Kabi?
English: EMA/763051/2014 EMEA/V/C/002757
Maltese: EMEA/V/C/002757
English: Suvaxyn CSF Marker is a recombinant veterinary vaccine that contains live bovine viral diarrhoea virus (BVDV) which has been modified to replace the envelope (E2) gene of BVDV with the corresponding gene of classical swine fever virus (CSFV).
Maltese: Suvaxyn CSF Marker huwa tilqima veterinarja rikombinanti li fiha l-virus tad-Dijarea Virali Bovina (BVDV) ħaj li ġie mmodifikat biex jissostitwixxi l-ġene envelopp (E2) tal-BVDV bil-ġene korrispondenti tal-virus tad-deni klassiku tal-ħnieżer (CSFV).
English: The field study showed that vaccination with Suvaxyn CSF Marker resulted in 19 out of 20 piglets developing antibodies against E2 protein.
Maltese: L-istudju fil-qasam wera li t-tilqima b'Suvaxyn CSF Marker irriżultat fi 19 minn 20 qażquż li żviluppaw antikorpi kontra l-proteina E2.
English: Twenty piglets were given Suvaxyn CSF Marker and 10 piglets were given a placebo (dummy) injection.
Maltese: Għoxrin qażquż ingħataw Suvaxyn CSF Marker u 10 qżieqeż ingħataw injezzjoni plaċebo (finta).
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata marrakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti wkoll mill-EPAR).
English: The vaccine virus in Suvaxyn CSF Marker has been modified so that it will produce the E2 protein, which is part of the outer coat of the closely related virus CSFV, which it provides protection against.
Maltese: Il-virus tat-tilqima f'Suvaxyn CSF Marker ġie mmodifikat sabiex jipproduċi l-proteina E2, li hija parti mill-kisja ta' barra tal-virus CSFV li huwa relatat mill-qrib, li jipprovdi protezzjoni kontrih.
English: The vaccine has potential marker properties which may allow detection of pigs infected with field CSFV as distinct from Suvaxyn CSF Marker vaccinated pigs, in accordance with the DIVA principle (differentiation of infection from vaccination).
Maltese: It-tilqima għandha karatteristiċi marker potenzjali li jistgħu jippermettu d-detezzjoni ta' ħnieżer infettati b'CSFV bħala distinti minn ħnieżer imlaqqmin b'Suvaxyn CSF Marker, skont il-prinċipju DIVA (differenzjazzjoni tal-infezzjoni mit-tilqima).
English: As CSF is a notifiable disease, it is not possible to conduct standard field studies.
Maltese: Minħabba li CSF hija marda notifikabbli, mhuwiex possibbli li jitwettqu studji standard fil-qasam.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn CSF Marker on 10/02/2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Suvaxyn CSF Marker fil-10-02-2015.
English: The vaccine is available as a lyophilisate (freeze dried powder) and solvent for injection.
Maltese: It-tilqima hija disponibbli bħala lijofilizzat (trab imnixxef bl-iffriżar) u solvent għal injezzjoni.
English: The effectiveness of Suvaxyn CSF Marker was further investigated in a small scale study with 30 eight-week-old piglets.
Maltese: Leffikaċja ta' Suvaxyn CSF Marker ġew investigati iktar fi studju fuq skala żgħira bi 30 qażquż ta' tmien ġimgħat.
English: There are no known side effects with Suvaxyn CSF Marker when it is used according to the approved indication of the product information.
Maltese: Ma hemm ebda effett sekondarju b'Suvaxyn CSF Marker magħruf meta jintuża skont l-indikazzjoni approvata tal-informazzjoni tal-prodott.
English: Protection prevents mortality and reduces infection and disease.
Maltese: Ilprotezzjoni tipproteġi kontra l-mortalità u tnaqqas l-infezzjoni u l-marda.
English: Suvaxyn CSF Marker is a vaccine containing bovine viral diarrhoea virus, which can infect pigs but does not normally cause disease in them.
Maltese: Suvaxyn CSF Marker huwa tilqima li fih il-virus tad-dijarea virali bovina, li jista' jinfetta l-ħnieżer iżda normalment ma jikkawżalhomx mard fihom.
English: What is Suvaxyn CSF Marker?
Maltese: X'inhu Suvaxyn CSF Marker?
English: What is the risk associated with Suvaxyn CSF Marker?
Maltese: X'riskji huma assoċjati ma' Suvaxyn CSF Marker?
English: The laboratory studies showed that the vaccine had its full effect against CSFV by two weeks.
Maltese: L-istudji fil-laboratorji wrew li t-tilqima kellha l-aqwa effett kontra CSFV fi żmien ġimagħtejn.
English: Classical swine fever vaccine (live recombinant)
Maltese: Tilqima tad-deni klassiku tal-ħnieżer (ħaj rikombinanti)
English: Why has Suvaxyn CSF Marker been approved?
Maltese: Għaliex ġie approvat Suvaxyn CSF Marker?
English: How has Suvaxyn CSF Marker been studied?
Maltese: Kif ġie studjat Suvaxyn CSF Marker?
English: Ref. EMEA/313852/2009
Maltese: EMEA/562561/2009EMEA/313852/2009
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: 1 Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendat.
English: The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Maltese: Bruno Urbain u id-Dott. Michael Holzhauser-Alberti, rispettivament.
English: 3 August 2009 Doc.
Maltese: 3 ta' Awwissu 2009 Dok. ta' ref.
English: Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
Maltese: Il-florfenicol huwa antibijotiku sintetiku bi spettru wiesa' attiv kontra firxa ta' organiżmi, fosthom organiżmi Gram-negattivi u Gram-pożittivi.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal and Spain.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, Virbac S.A., ippreżenta applikazzjoni permezz tal-proċedura ta' rikonoxximent reċiproku għal Shotaflor 300 mg/ml soluzzjoni injettabli għallbhejjem tal-ifrat, abbażi tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mir-Renju Unit. Lapplikazzjoni ġiet ippreżentata fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendata, li fih l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Awstrija, ilBelġju, id-Danimarka, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, l-Olanda, il-Portugall u Spanja.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR SHOTAFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Maltese: OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 33(4)1 GĦAL
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Shotaflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Maltese: Minħabba xi tħassib, imqajjem mill-Ġermanja u mill-Olanda matul il-proċedura ta' rikonoxximent reċiproku, dwar il-fatt li Shotaflor 300 mg/ml soluzzjoni injettabbli għall-bhejjem tal-ifrat seta' jippreżenta riskju potenzjali gravi għall-ambjent, ir-Renju Unit irrefera l-kwistjoni lill-EMEA fil-31 ta' Lulju 2008 skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: Written explanations were provided by the Marketing Authorisation Holder on 15 January 2009.
Maltese: Ingħataw spjegazzjonijiet bilmiktub mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fil-15 ta' Jannar 2009. Lispjegazzjonijiet orali ngħataw fis-16 ta' April 2009.
English: The referral procedure started on 16 September 2008.
Maltese: Il-proċedura ta' referenza bdiet fis-16 ta' Settembru 2008.
English: The Marketing Authorisation Holder, Virbac S.A., submitted an application via mutual recognition for Shotaflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Maltese: Shotaflor 300 mg/ml soluzzjoni injettabbli għall-bhejjem tal-ifrat
English: However, the CVMP also considered that the wording of the therapeutic indication as authorised in the Reference Member State should be amended to clearly state the limitations of the approved use and avoid incorrect interpretation.
Maltese: Madankollu, is-CVMP kkunsidra li l-kliem tal-indikazzjoni terapewtika kif inhi awtorizzata mill-Istat Membru ta' Referenza għandu jiġi emendat biex jiġu dikjarati b'mod ċar illimitazzjonijiet tal-użu approvat u sabiex jiġi evitat li jkun interpretat b'mod żbaljat.
English: Therefore the Committee adopted an opinion on 14 May 2009 recommending the variation of the Marketing Authorisation in line with the proposed amendments to the Summary of Product Characteristics and package leaflet.
Maltese: Għalhekk, ilKumitat adotta opinjoni fl-14 ta' Mejju 2009 li fiha rrakkomanda l-varjazzjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq konformi mal-emendi proposti lis-Sommarju tal-Karatteristiċi tal-Prodott u lillfuljett ta' tagħrif.