FrancophonIA/ELRC3.0 huggingface dataset:
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Maltese: Matul il-perjodu ta' wara l-awtorizzazzjoni għat-tqegħid fis-suq ta' Kineret, ġiet irrappurtata ttromboċitopenija, fosthom rapporti ta' każijiet okkażjonali li indikaw tromboċitopenija serja (jiġifieri numru ta' pjastrini <10 x109/l).
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10):
English: Route of administration
Maltese: Metodu ta'amministrazzjoni
English: EU Number Invented Name
Maltese: Numru EU Isem mgħoti
English: Horses Intramuscular Vials (Type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Maltese: Vjal tal-ħġieġ Tip I magħluq b tapp talgomma u ssiġillat b' kappa talaluminjum.
English: 1 dose 10 pre-filled syringes
Maltese: 10 vjali tal-ħġieġ
English: Horses Intramuscular Pre-filled syringes (Type I glass) with a plunger and cap tip of halogenobutyl rubber
Maltese: Siringa talħġieġ Tip I , mimlija għallest bi planġer b'tarf talgomma u magħluq b'tapp talgomma.
English: Content Package size Withdrawal period
Maltese: Ippakjar Kontenut Qies talpakett
English: 1 dose 10 glass vials Zero days
Maltese: 10 siringi mimlija għal-lest
English: Target species
Maltese: Perjodu ta'tiżmim
English: ml
Maltese: Qawwa
English: EU/1/16/1121/001 Zalmoxis
Maltese: EU/1/16/1121/001 Zalmoxis 5-20 x 106 ċelluli/mL Dispersjoni għall-infużjoni
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Maltese: Borża li tista' tiġi ffriżata magħmula minn ethylen-vinyl-acetate (EVA)
English: Immediate Packaging Content Pack size
Maltese: Kontenut Daqs tal-pakkett
English: 5-20 x 106 cells/mL
Maltese: 10-100 ml
English: Route of Administration
Maltese: Borża waħda
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110
Maltese: Il-Lussemburgu NV AstraZeneca SA Egide Van Ophemstraat
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens, Greece
Maltese: Theotokopoulou & Astronafton str 151 25
English: 1, Place Renault 92844 RUEIL-MALMAISON Cedex
Maltese: 1, Place Renault 92844
English: AstraZeneca A/S Arne Jacobsens Allé 13 2300 Copenhagen S Denmark
Maltese: Id-Danimarka AstraZeneca A/S Arne Jacobsens Allé 13 2300 Copenhagen S Denmark
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Maltese: NV AstraZeneca SA Egide Van Ophemstraat
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Maltese: Sforza 20080 - Basiglio (Milano) Italy
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
English: Luton LU1 3LU
Maltese: Il-Pajjiżi l-Baxxi
English: Solution for infusion
Maltese: Soluzzjoni għallinfużjoni
English: Seebri Breezhaler (glycopyrronium bromide) EMA/326863/2018
Maltese: Seebri Breezhaler (bromur tal-glikopirronju)EMA/326863/2018
English: Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Seebri Breezhaler tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Seebri Breezhaler (glycopyrronium bromide)
Maltese: Seebri Breezhaler (bromur tal-glikopirronju)
English: Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Seebri Breezhaler huwa mediċina użata biex ittaffi s-sintomi tal-marda pulmonari ostruttiva kronika (COPD) fl-adulti.
English: Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Maltese: Seebri Breezhaler instab li kien aktar effettiv mill-plaċebo (kura finta) fit-taffija tas-sintomi ta' COPD f'żewġ studji ewlenin li involvew total ta' 1, 888 pazjent b'COPD.
English: The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Maltese: L-effetti sekondarji l-aktar komuni b'Seebri Breezhaler (li dehru f'aktar minn pazjent 1 minn 100) huma ħalq xott, nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), insomnja (diffikultà flirqad), uġigħ fl-għadam u l-muskoli u gastroenterite (dijarrea u remettar).
English: The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Maltese: Is-sustanza attiva f'Seebri Breezhaler, il-bromur tal-glikopirronju, hija antagonista tar-riċettur muskariniku.
English: Seebri Breezhaler contains the active substance glycopyrronium bromide.
Maltese: Seebri Breezhaler fih is-sustanza attiva bromur tal-glikopirronju.
English: How does Seebri Breezhaler work?
Maltese: Kif jintuża Seebri Breezhaler?
English: Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012.
Maltese: Seebri Breezhaler irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Settembru 2012.
English: After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Maltese: Wara 12-il ġimgħa ta' kura, Seebri Breezhaler żied FEV1 b'97 ml aktar mill-plaċebo fl-ewwel studju, u b'108 ml aktar fit-tieni studju.
English: Seebri Breezhaler is used for maintenance (regular) treatment.
Maltese: Seebri Breezhaler jintuża għall-kura ta' manutenzjoni (regolari).
English: As for all medicines, data on the use of Seebri Breezhaler are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Seebri Breezhaler hija ssorveljata kontinwament.
English: In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Maltese: Barra minn dan, ma kien hemm ebda tħassib maġġuri dwar is-sigurtà b'Seebri Breezhaler, b'effetti sekondarji li huma simili għal mediċini antagonisti tar-riċettur muskariniku.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: effikaċja kien it-titjib fil-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ f'sekonda).
English: For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Seebri Breezhaler, ara l-fuljett ta' tagħrif.
English: Other information about Seebri Breezhaler
Maltese: Informazzjoni oħra dwar Seebri Breezhaler
English: What are the risks associated with Seebri Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Seebri Breezhaler?
English: Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Maltese: Ir-riċetturi muskariniċi jikkontrollaw il-kontrazzjoni tal-muskoli u meta l-bromur tal-glikopirronju jkun inalat, dan jirrilassa l-muskoli tal-passaġġi tal-arja.
English: An overview of Seebri Breezhaler and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Seebri Breezhaler u għalfejn huwa awtorizzat fl-EU
English: How is Seebri Breezhaler used?
Maltese: Kif jaħdem Seebri Breezhaler?
English: Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Seebri Breezhaler huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The full EPAR for Memantine LEK can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Memantine LEK jista' jinstab ukoll fuq is-sit tal-internet tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Memantine LEK is a ‘generic medicine'.
Maltese: Memantine LEK huwa ‘mediċina ġenerika'.
English: The active substance in Memantine LEK, memantine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Memantine LEK, il-memantina, hija mediċina kontra d-dimenzja.
English: This is a summary of the European public assessment report (EPAR) for Memantine LEK.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Memantine LEK.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine LEK on 22 April 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Memantine LEK fil-22 April 2013.
English: Memantine LEK is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Maltese: Memantine LEK jiġi f'pilloli ta' 10 mg u 20 mg u jista jinkiseb biss b'riċetta ta' tabib.
English: Memantine LEK is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Memantine LEK huwa mediċina li tintuża għat-trattament ta' pazjenti bil-marda ta' Alzheimer moderata sa gravi, tip ta' dimenzja (disturb fil-moħħ) li b'mod gradwali taffettwa l-memorja, il-kapaċità intellettwali u l-imġiba.
English: Why is Memantine LEK approved?
Maltese: Għaliex ġie approvat Memantine LEK?
English: This means that Memantine LEK is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Maltese: Dan ifisser li Memantine LEK huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Ebixa.
English: To prevent side effects, the dose of Memantine LEK is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Memantine LEK tiżdied b'mod gradwali matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: Because Memantine LEK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Memantine LEK huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Memantine LEK
Maltese: Kif jintuża Memantine LEK?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Memantine LEK għandu kwalità komparabbli u huwa bijoekwivalenti għal Axura.
English: Because Memantine LEK is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Axura.
Maltese: Peress li Memantine LEK huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Axura.
English: The Committee recommended that Memantine LEK be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Memantine LEK ikun approvat għall-użu fl-UE.
English: How has Memantine LEK been studied?
Maltese: Kif ġie studjat Memantine LEK?
English: What are the benefits and risks of Memantine LEK?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Memantine LEK ?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine LEK, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Memantine LEK, fosthom il-prekawzjonijiet xierqa li jridu jkunu segwiti mill-professjonisti filkura tas-saħħa u l-pazjenti.
English: Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Axura, il-benefiċċji huma akbar mir-riskji identifikati.
English: How is Memantine LEK used?
Maltese: Kif jaħdem Memantine LEK?
English: 1 bottle + 1 adapter + 1 oral applicator
Maltese: 1 Flixkun + 1 adapter + 1 applikatur tal-ħalq
English: Content (concentration) Package size
Maltese: Kontenut (Konċentrazzjoni)
English: Oral solution bottle (HDPE) 230 ml
Maltese: Flixkun (HDPE)
English: Route of administration
Maltese: Soluzzjoni orali
English: Scientific conclusions
Maltese: Il
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għall-aġenti antivirali li jaħdmu b'mod dirett (DAAs)
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk
Maltese: B'mod ġenerali, il-PRAC kien tal-fehma li l-evidenza turi riskju ta' riattivazzjoni tal-HBV f'pazjenti koinfettati bl-HBV/HCV ikkurati b'DAAs u għalhekk ir-riattivazzjoni tal-HBV f'pazjenti koinfettati għandha tiġi kkunsidrata bħala riskju identifikat importanti li jeħtieġ li jiġi mmonitorjat aktar mill-qrib permezz ta' attivitajiet ta' rutina ta' minimizzazzjoni tar-riskju.
English: In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and
Maltese: F'konformità mar-rakkomandazzjoni tal-PRAC, sabiex tiġi evalwata r-rikorrenza tal-karċinoma epatoċellulari assoċjata ma' antivirali li jaħdmu b'mod dirett, il-MAHs għandhom iwettqu u jippreżentaw ir-riżultati ta' studju prospettiv dwar is-sigurtà li juża data derivata minn koorti ta' grupp ta' pazjenti definit tajjeb, ibbażat fuq protokoll miftiehem li jistabbilixxi kriterji għad-dħul u s-segwitu ta' pazjenti f'termini ta' żmien u metodu tal-iskrinjar.
English: CHMP opinion and detailed explanation of the scientific grounds for the differences from the
Maltese: L-opinjoni tas-CHMP u spjegazzjoni dettaljata tar-raġunijiet xjentifiċi għad-differenzi mir
English: The RMP of the relevant medicinal products will be updated accordingly.
Maltese: L-RMP tal-prodotti mediċinali rilevanti se jiġi aġġornat kif
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested
Maltese: Għalhekk, f'April 2016, il-Kummissjoni Ewropea estendiet ilkamp ta' applikazzjoni tal-proċedura sabiex tippermetti konsiderazzjoni ta' data oħra biex jiġi evalwat ir-riskju tal-karċinoma epatoċellulari u l-impatt tagħha fuq il-bilanċ bejn il-benefiċċju u r-riskju għadDAAs kollha fil-kura tal-epatite Ċ kronika.
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral
Maltese: • Il-PRAC irrieżamina t-totalità tad-data ppreżentata bil-miktub u waqt l-ispjegazzjonijiet bilfomm mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fir-rigward tar-riskju tarriattivazzjoni tal-epatite B u t-tħassib li tqajjem wara r-rapporti tal-karċinoma epatoċellulari f'pazjenti bl-użu ta' DAAs, kif ukoll ir-riżultat tal-laqgħa tal-grupp konsultattiv xjentifiku dwar l
English: EU/1/17/1226/001 LUTATHERA 370 MBq/ml
Maltese: EU/1/17/1226/001 LUTATHERA
English: 20.5 - 25 ml
Maltese: Użu għal ġol-vini kunjett (ħġieġ) 20.5 - 25 mL
English: Content (concentration)
Maltese: (konċentrazzjoni
English: Content (concentration)
Maltese: Kontenut (konċentrazzjon i)
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack)
Maltese: 1 ml (100 mg/ml) 3 (3 x 1) siringi mimlijin għal-lest (pakkett multiplu)
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled pens (multipack)
Maltese: 1 ml (100 mg/ml) 3 (3 x 1) pinen mimlijin għal-lest (pakkett multiplu)
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Maltese: 1 ml (100 mg/ml) pinna mimlija għal-lest 1
English: International non-proprietary name (INN): florfenicol
Maltese: Denominazzjoni internazzjonali komuni (INN): florfenikolu
English: The reference product was Nuflor Swine Injectable Solution 300 mg/ml (FR/V/0118/001).
Maltese: Il-prodott ta' referenza kien Nuflor Swine Injectable Solution 300 mg/ml (FR/V/0118/001).
English: Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.
Maltese: Florfenicol huwa strutturalment relatat mat-tijamfenikolu u għandu profil farmakoloġiku simili.
English: Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure (DE/V/0132/001/DC) with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Maltese: Florgane 300 mg/ml sospensjoni għallinjezzjoni ġie awtorizzat għall-użu fil-frat bħala ibridu ta' Nuflor 300 mg/ml soluzzjoni għall-injezzjoni permezz ta' proċedura deċentralizzata (DE/V/0132/001/DC) bil-Ġermanja bħala Stat Membru ta' referenza u l-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, id-Danimarka, Franza, il-Greċja, lUngerija, l-Irlanda, l-Italja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, irRumanija, is-Slovakkja, Spanja u r-Renju Unit bħala Stati Membri inkwistjoni.
English: The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur.
Maltese: Il-Kumitat ħatar lill-Prof. Christian Friis bħala rapporteur u lil Dr Cornelia Ibrahim bħala ko-rapporteur.
English: Written explanations were provided by the applicant on 11 September 2012 and 9 January 2013.
Maltese: L-applikant ipprovda spjegazzjonijiet bilmiktub fil-11 ta' Settembru 2012 u fid-9 ta' Jannar 2013.
English: Veterinary Medicines and Product Data Management
Maltese: Mediċini Veterinarji u Ġestjoni tad-Dejta tal-Prodotti
English: This extension application (DE/V/0132/001/DX/001) was submitted according to the same procedure (DCP) and type of application (hybrid, according to Article 13(3) of Directive 2001/82/EC) as for the initial application for cattle, to the same Member States.
Maltese: Din l-applikazzjoni għal estensjoni (DE/V/0132/001/DX/001) kienet sottomessa skont l-istess proċedura (DCP) u tip ta' applikazzjoni (ibridu, skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE) bħal dik tal-applikazzjoni inizjali għall-frat, lill-istess Stati Membri.
English: Oral explanations were given on 5 March 2013.
Maltese: Spjegazzjonijiet orali ngħataw fil-5 ta' Marzu
English: Potential serious risks were identified during the decentralised procedure by Denmark regarding the efficacy of the product and the potential for development of antimicrobial resistance to florfenicol.
Maltese: Ġew identifikati riskji serji potenzjali waqt il-proċedura deċentralizzata mid-Danimarka rigward l-effikaċja tal-prodott u l-potenzjal ta' żvilupp ta' reżistenza antimikrobjali għall-florfenikolu.
English: The applicant, Emdoka bvba, submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Maltese: L-applikant, Emdoka bvba, issottometta applikazzjoni għal proċedura deċentralizzata għal Florgane 300 mg/ml sospensjoni għall-injezzjoni fil-frat u l-ħnieżer u ismijiet assoċjati.
English: Florgane 300 mg/ml suspension for injection for cattle and pigs contains florfenicol as active ingredient and is intended for use in pigs for the treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Maltese: Florgane 300 mg/ml, sospensjoni għall-injezzjoni fil-frat u l-ħnieżer, fiha l-florfenikolu bħala sustanza attiva u hija maħsuba għall-użu fil-ħnieżer għall-kura ta' tifqigħat akuti ta' mard respiratorju kkawżat minn razez ta' Actinobacillus pleuropneumoniae u Pasteurella multocida suxxettibbli għall-florfenikol.
English: The referral procedure started on 15 May 2012.
Maltese: Il-proċedura ta' referenza bdiet fil-15 ta' Mejju 2012.
English: The decentralised procedure started on 17 December 2010.
Maltese: Il-proċedura deċentralizzata bdiet fis-17 ta' Diċembru 2010.
English: Opinion following an Article 33(4)1 referral for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names
Maltese: Opinjoni wara referenza skont l-Artikolu 33(4)0F għal Florgane 300 mg/ml sospensjoni għall-injezzjoni fil-frat u l-ħnieżer u ismijiet assoċjati
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 February 2012.
Maltese: Fil-210 jum, dawn il-kwistjonijiet baqgħu ma ssolvewx u għalhekk inbdiet referenza skont lArtikolu 33(1) tad-Direttiva 2001/82/KE lill-Grupp ta' koordinazzjoni għall-proċeduri ta' Rikonoxximent Reċiproku u Deċentralizzati (veterinarji) (CMD(v)) fl-20 ta' Frar 2012.
English: The proposed dose is 22.5 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Maltese: Id-doża proposta hija 22.5 mg florfenikol għal kull kg ta' piż tal-ġisem li tingħata bħala injezzjoni waħda fil-muskolu.
English: On 19 April 2012, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fid-19 ta' April 2012, l-Istat Membru ta' referenza, il-Ġermanja, innotifika lill-Aġenzija Ewropea għallMediċini li s-CMD(v) kien naqas li jilħaq ftehim dwar il-prodott u rrefera l-kwistjoni lis-CVMP skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.