FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibition of BCRP by canagliflozin cannot be excluded at an intestinal level and increased exposure may therefore occur for medicinal products transported by BCRP, e.g. certain statins like rosuvastatin and some anti-cancer medicinal products.
Maltese: Ma tistax tiġi eskluża inibizzjoni ta' BCRP b'canagliflozin fil-livell tal-intestini u għalhekk tista' sseħħ żieda fl-esponiment għall-prodotti mediċinali ttrasportati minn BCRP, eż. ċerti statins bħal rosuvastatin u xi prodotti mediċinali oħra ta' kontra l-kanċer.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Il-pazjenti li jistgħu jkunu f'riskju akbar għal DKA jinkludu pazjenti b'riserva baxxa ta' funzjoni taċ ċelluli beta (eż., pazjenti b'dijabete tat-tip 2 b'peptide C baxx jew dijabete awtoimmuni latenti fl-adulti (LADA - latent autoimmune diabetes in adults) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal ammont ristrett fl-ikel li jittiekel jew deidratazzjoni severa, pazjenti li għalihom id-dożi tal-insulina jiġu mnaqqsa u pazjenti b'żieda fil-ħtieġa għall-insulina minħabba mard mediku akut, operazzjoni jew abbuż tal-alkoħol.
English: The legal basis under which the application was submitted is Art 10(1) in combination with Art. 28(3) of Directive 2001/83/EC, as amended.
Maltese: Il-bażi legali li taħtha ġiet sottomessa l-applikazzjoni hija l-Art 10(1) f'kombinazzjoni mal-Art. 28(3) tadDirettiva 2001/83/KE, kif emendat.
English: It was argued by the objecting CHMP members that according to the Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product (EMEA/CHMP/QWP/396951/2006) and the Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal Products (CPMP/CVMP/QWP/115/95), the use of antioxidants should be avoided whenever possible.
Maltese: Kien argumentat mill-membri tas-CHMP li għamlu loġġezzjoni li skont il-Linja Gwida dwar Sustanzi mhux Attivi fid-Dossier għall-Applikazzjoni għallAwtorizzazzjoni tat-Tqegħid fis-Suq tal-Prodott Mediċinali EMEA/CHMP/QWP/396951/2006) u n-Nota għal Gwida dwar l-Inklużjoni ta' Antiossidanti u Preservattivi Antimikrobjali fil-Prodotti Mediċinali (CPMP/CVMP/QWP/115/95), kull meta jkun possibbli, l-użu ta' antiossidanti għandu jiġi evitat.
English: - Clinical issues
Maltese: - Kwistjonijiet kliniċi
English: Batch analysis results have demonstrated consistent quality.
Maltese: Riżultati tal-analiżi tal-lottijiet uriet kwalità konsistenti.
English: The issue was referred to the CMD(h) and an assessment was carried out by the Reference Member State (RMS).
Maltese: Il-kwistjoni ġiet tiferuta lis-CMD(h) u saret evalwazzjoni mill-Istat Membri ta' Referenza (RMS).
English: GROUNDS FOR POSITIVE OPINION
Maltese: RAĠUNIJIET GĦAL OPINJONI POŻITTIVA
English: are bioequivalent to the reference medicinal product clopidogrel bisulphate
Maltese: huma bijoekwivalenti għall-prodott mediċinali clopidogrel bisulphate
English: Clopidogrel is a non-competitive inhibitor of adenosine diphosphate (ADP) at the platelet receptors.
Maltese: Clopidofrel huwa inibitur mhux kompetittiv ta' adenosine diphosphate (ADP) fir-riċetturi tal-plejtlits.
English: The adenylate cyclase-coupled ADP receptor P2Y12 is the main target of clopidogrel and leads to inhibition of platelet activation, aggregation, and Gp IIb/IIIa receptor activation.
Maltese: Irriċettur ADP adenylate cyclase-coupled P2Y12 huwa l-mira prinċipali ta' clopidogrel u jwassal għallinibizzjoni ta' attivazzjoni, aggregazzjoni tal-plejtlits u għall-attivazzjoni tar-riċetturi GpIIb/IIIa.
English: Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product.
Maltese: Mid-19-il episodju avvers, 14 kienu għall-prodott ta' referenza u 5 għall-prodott taħt studju.
English: In the bioequivalence study, a total of 19 adverse events were reported by 13 subjects.
Maltese: Fl-istudju ta' bijoekwivalenza, ġew irrapportati total ta' 19-il episodju avvers minn 13-il suġġett.
English: The acetic acid impurity (a major degradant) was found to be controlled in the Applicant's clopidogrel Tablets 75 mg as compared to Plavix 75 mg (Clopidogrel Bisulphate Tablet 75 mg).
Maltese: L-impurità ta' aċidu aċetiku (degradant prinċipali) instab illi kienet ikkontrollata filPilloli ta' clopidogrel ta' 75 mg tal-Applikant kif imqabbel ma' Plavix 75 mg (Pillola ta' Clopidogrel Bisulphate ta' 75 mg).
English: Clopidogrel is indicated for the prevention of atherothrombotic events in patients suffering from myocardial infarction or acute coronary syndrome.
Maltese: Clopidogrel huwa indikat għall-prevenzjoni ta' episodji aterotrombotiċi f'pazjenti li jsofru minn infart mijokardiku jew sindromu koronarju akut.
English: When clopidogrel bisulfate (as in Reference product) and clopidogrel base (as in Test product) were administered as a single dose to healthy volunteers in this study, the drug products were well tolerated with no serious adverse events for either, and no relevant difference in the safety profiles of the test and reference formulation was observed with regard to the number and pattern of adverse events.
Maltese: Meta clopidogrel bisulphate (bħal fil-prodott ta' Referenza) u l-bażi ta' clopidogrel (bħal fil-prodott Test) ġew amministrati bħala doża singola lil voluntiera b'saħħithom fl-istudju, il-prodotti mediċinali kienu ttollerati tajjeb mingħajr episodju avvers serju għat-tnejn, u mingħajr ma ġiet osservata differenza relevanti fil-profili ta' sigurtà tal-formolazzjoni tat-test u ta' referenza fir-rigward tan-numru u l-forma ta' episodji avversi.
English: are stable in comparison to clopidogrel bisulphate, which is sensitive to hydrolytic degradation.
Maltese: - huma stabbli meta mqabblin ma' clopidogrel bisulphate, li huwa sensittiv għal degradazzjoni idrolitika.
English: - Quality issues
Maltese: - Kwistjonijiet ta' kwalità
English: The reference medicinal product for this generic application is Plavix (Clopidogrel Hydrogen sulphate) 75 mg film-coated tablets.
Maltese: Il-prodott mediċinali ta' referenza għal din l-applikazzjoni ġenerika huwa Plavix (Clopidogrel Hydrogen sulphate) pilloli miksijin b'rita ta' 75 mg.
English: The use of the unstable clopidogrel base as active substance necessitated the use of the antioxidant butylated hydroxyl anisol (BHA) for stabilisation.
Maltese: L-użu tal-bażi instabbli ta' clopidogrel bħala sustanza attiva ħoloq il-ħtieġa tal-użu tal-antiossidant butylated hydrolxyl anisol (BHA) għal stabilizzazzjoni.
English: Taking into consideration the literature survey, the taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts and free base of clopidogrel were considered.
Maltese: B'kunsiderazzjoni għall-istħarriġ tar-riċensjoni, ġew ikkunsidrati l-imluħa ta' taurocholate, hydrochloride, hydrobromide u hydrogen sulphate u bażi ħielsa ta' clopidogrel.
English: Overall, it is claimed by the Applicant that their clopidogrel tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product.
Maltese: B'mod ġenerali, l-Applikant jisħaq li l-pilloli ta' clopidogrel ta' 75 mg tiegħu għandhom kwalità u propozjon benefiċċju/riskju adegwati u huma komparabbli mal-prodott ta' referenza.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CLOPIDOGREL ORION
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' CLOPIDOGREL ORION
English: From the data provided the Applicant claimed that clopidogrel tablets 75 mg are stable when compared to Plavix 75 mg (Clopidogrel Bisulphate Tablets 75 mg).
Maltese: Mid-dejta pprovduta, l-Applikant jistqarr li l-pilloli ta' clopidogrel ta' 75 mg huma stabbli meta mqabbla ma' Plavix 75 mg (Clopidogrel Bisulphate Tablets 75 mg).
English: Clopidogrel is known to hydrolyse and to form a hydrolytic impurity i.e an acetic acid impurity, which is a major degradant.
Maltese: Clopidogrel huwa magħruf illi jidrolizza ruħu u li jifforma impurità idrolitika jiġifieri impurità ta' aċidu aċetiku, li huwa degradant prinċipali.
English: Based on the information presented, taurocholate, hydrochloride, hydrobromide and hydrogen sulphate salts of clopidogrel were found to be unsuitable for product development for various reasons.
Maltese: Fuq il-bażi tal-informazzjoni ppreżentata, l-imluħa ta' cloridogrel ma' taurocholate, hydrochloride, hydrobromide u hydrogen sulphate nstabu li mhumiex xierqa għall-iżvilupp tal-prodott għal diversi raġunijiet.
English: Although the clopidogrel free base posed the challenges of converting an unstable, gummy and sticky nature into a granular, free flowing and stable material for use in formulations, the Applicant chose the clopidogrel free base as the suitable candidate for product development.
Maltese: Għalkemm il-bażi ħielsa ta' clopidogrel ippreżentat sfidi għall-konverżjoni ta' natura twaħħal, gommuża u instabbli għal materjal stabbli, bi fluss liberu u granullari għall-użu f'formulazzjonijiet, lApplikant għażel il-bażi ħielsa ta' clopidogrel bħala l-kandidat xieraq għall-iżvilupp tal-prodott.
English: In addition, the CHMP was also concerned that it had not been demonstrated that the proposed production and quality control methods could guarantee that a major deficiency in the quality of the product would not occur.
Maltese: Barra minn hekk, is-CHMP kien imħasseb ukoll li ma ntweriex li l-produzzjoni proposta u l-metodi ta' kontroll tal-kwalità jistgħu jiggarantixxu li mhux sejra sseħħ defiċjenza prinċipali fil-kwalità tal-prodott.
English: The Applicant explained that the amount of BHA from clopidogrel tablets was no more than 0.75% of its ADI, which was argued to be a negligible.
Maltese: L-Applikant spjega li l-ammont ta' BHA mill-pilloli ta' clopidogrel kien mhux aktar minn 0.75% tal-ADI tiegħu, li kien argumentat li huwa negliġibbli.
English: The Clopidogrel Orion 75 mg Film coated Tablets:
Maltese: Ilpilloli Clopidogrel Teva ta' 75 mg miksijin b'rita:
English: As the clopidogrel base corresponds to an unstable, viscous mass, the drug substance is stabilized by means of a premix, which contains the antioxidant butylated hydroxy anisol (BHA).
Maltese: Minħabba li l-bażi ta' clopidogrel tikkorrispondi għal massa viskuża instabbli, is-sustanza mediċinali hija stabbilizzata permezz ta' taħlita minn qabel, li fiha l-antiossidant butylated hydroxy anisol (BHA).
English: Sweden
Maltese: MEMBRI
English: The drug substance and the drug product manufacturer have been shown to be capable of producing a, stable product essentially similar in efficacy and safety to the reference product.
Maltese: Il-manifatturi tas-sustanza mediċinali u tal-prodott mediċinali ntwerew li huma kapaċi li jipproduċu prodott stabbli essenzjalment simili fl-effikaċja u s-sigurtà għall-prodott ta' referenza.
English: The Applicant addressed the long-term safety of BHA at the oral explanation before the CHMP on 17 February 2010, by making reference to the Acceptable Daily Intake (ADI), an estimate of the amount of BHA that can be ingested on a daily basis over a lifetime without appreciable risk to health.
Maltese: L-applikant indirizza s-sigurtà fuq perjodu ta' żmien twil ta' BHA bi spjegazzjoni orali quddiem is-CHMP fis-17 ta' Frar 2010, billi għamel referenza għat-Teħid Aċċettabbli ta' Kuljum (ADI), stima tal-ammont ta' BHA li jista' jinbela' ta' kuljum matul il-ħajja mingħajr riskju apprezzabbli fuq is-saħħa.
English: Three out of the nineteen adverse events did not require any medical intervention.
Maltese: Tlieta middsatax-il episodju avvers ma kellhomx bżonn ta' intervent mediku.
English: The Applicant attended the CHMP meeting for an oral explanation on 17 February 2010 to present their position with regard to the choice of clopidogrel base as the active substance compared to the more stable clopidogrel salts, and also to discuss the safety of the long-term use of BHA.
Maltese: L-Applikant attenda l-laqgħa tas-CHMP għal spjegazzjoni orali fis-17 ta' Frar 2010 biex jippreżenta lpożizzjoni tiegħu fir-rigward tal-għażla tal-bażi ta' clopidogrel bħala s-sustanza attiva meta mqabbla ma' mluħa ta' clopidogrel aktar stabbli, u wkoll biex jiddiskuti s-sigurtà tal-użu għal perjodu ta' żmien twil ta' BHA.
English: - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Maltese: Billi - l-għażla tal-Applikant għall-bażi ta' clopidogrel u konsegwentament l-użu ta' BHA ġie spjegat b'mod suffiċjenti - l-istrateġija ta' kontroll ġenerali biex tiżgura kwalità xierqa u riproduċibbli tal-prodott ġiet iġġustifikata firrigward ta' maniġġ tal-massa viskuża tal-bażi ta' clopidogrel - il-Pilloli bil-Bażi ta' Clopidogrel ta' 75 mg tal-Applikant għandhom kwalità u proporzjon ta' benefiċċju/riskju adegwati u huma kumparabbli mal-prodott ta' referenza is-CHMP irrakkomanda illi tingħata l-Awtorizzazzjoni għat-Tqegħid fis-Suq li għaliha, is-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali milħuqa waqt ilproċedura tal-grupp ta' Kordinament kif imsemmi fl-Anness
English: The product is formulated as immediate release tablets containing 75 mg clopidogrel.
Maltese: Il-prodott huwa fformulat bħala pilloli ta' rilaxx immedjat li fihom 75 mg ta' clopidogrel.
English: ENGLISH
Maltese: MALTESE
English: STORING X
Maltese: KIF TAĦŻEN X
English: <Store in a freezer>
Maltese: <Aħżen fil-friża>
English: <Store in a refrigerator (2(C - 8(C)>
Maltese: <Aħżen fi friġġ (2(C - 8(C)>
English: <Store and transport frozen>**
Maltese: <Żommu <fil-pakkett> oriġinali>****
English: B. PACKAGE LEAFLET
Maltese: KARATTERISTIĊI
English: <Store and transport frozen {temperature range}>**
Maltese: <Żomm iffriżat waqt il-ħażna u l-ġarr {il-limiti tat-temperatura}>**
English: <Store in a freezer {temperature range}>
Maltese: <Aħżen fil-friża {il-limiti tat-temperatura}>
English: <Store and transport refrigerated (2(C - 8(C)>*
Maltese: <Żommu kiesaħ waqt il-ħażna u l-ġarr (2(C - 8(C)>*
English: A. LABELLING
Maltese: A.
English: 3732 CN De Bilt
Maltese: 3732 CN De Bilt Olanda
English: Netherlands
Maltese: Olanda
English: ATC-vet code: QI01AA23.
Maltese: QI01AA23
English: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Maltese: Antiġen sħiħ inattivat tal-virus tal-influwenza avjarja, subtip H5N2 (strejn A/duck/Potsdam/1402/86), li jinduċi titru ta' HI ta' ≥6.0log2, kif ittestjat skont it-test ta' potenza.
English: Date of last renewal: 23/08/2011
Maltese: Data tal-aħħar tiġdid: 23.08.2011
English: Liquid light paraffin Polysorbate 80
Maltese: Paraffina likwida ħafifa Polysorbate 80
English: MARKETING AUTHORISATION NUMBER EU/2/06/061/001-004
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/061/001 - 004
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: Use sterile syringes and needles.
Maltese: Uża' siringi u labar sterili.
English: INDICATION
Maltese: INDIKAZZJONI
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/061/001-004
Maltese: NUMRU TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/06/061/001 - 004
English: Poligono Industrial El Montalvo I C/Zeppelin 6, Parcela 38
Maltese: Poligono Industrial El Montalvo I C/Zeppelin 6, Parcela 38 37008 Carbajosa de la Sagrada Salamanca Spanja
English: Cardboard box with 250 or 500 ml hydrolytical type II glass or polyethylene terephthalate (PET) bottles.
Maltese: Kaxxa tal-kartun b'250 jew 500 ml, ħġieġ idrolitika tip II, jew fliexken tal-poli-etilin tereftalejt (PET).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use (0.25 to 0.5 ml, depending on the age).
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Uża fil-muskolu jew taħt il-ġilda (0.25ml sa 0.5ml, skont l-età.
English: Allow the vaccine to reach a temperature of 15 °C - 25 °C.
Maltese: Ħalli t-tilqim jilħaq temperatura ta'15°C - 25°C
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: Chickens.
Maltese: Tiffriżax.
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: The manufacture, import, possession, sale, supply and/or use of Nobilis Influenza H5N2 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Peress li l-manifattura, importazzjoni, pussess, bejgħ, provista u / jew l-użu ta' Nobilis Influenza H5N2 jista' jkun ipprojbit fi Stat Membru jew ġo parti mit-Territorju tiegħu leġislazzjoni nazzjonali tagħhom, kull persuna għandhal-ewwel tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar ilprogrammi ta' tilqim kurrenti.
English: Pharmacotherapeutic group: Immunologicals for Aves; Inactivated viral vaccines, avian influenza virus.
Maltese: Immunoloġiku għat-tjur, vaċċin virali inattivat, virus tal-influenza tattjur.
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, prohibitthe 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 amendat, Stat Membru, jista', skont il-leġiżlazzjoni nazzjonali, jipprojbixxi l-manifattura, l-importazzjoni, il-bejgħ, ilforniment u/jew l-użu tal-prodott mediċinali veterinarju immunoloġiku fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {Nru.}
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bijoloġika attiva
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: Peress li s-sustanza attiva hija fil-prinċipju ta' natura bijoloġika u intiża biex tipproduċi immunità attiva ma taqax fl-iskop tar-Regoli (EC) No 470/2009.
English: The vaccine stimulates active immunity against avian influenza virus type A, subtype H5.
Maltese: Il-vaċċin jistimula immunità attiva kontra l-virus tal-Influwenza Avjarja tip A, subtip H5.
English: If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Maltese: Jekk il-virus tal-influwenza avjarja li qed jiċċirkula fil-beraħ għandu l-komponent N tiegħu differenti mill-N2, inkluż fil-vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijanjostiku li jagħraf antikorpi Nuraminidejs.
English: For active immunisation of chickens against avian influenza type A, subtype H5.
Maltese: Għal immunizzazzjoni attiva fil-flieles kontra l-Influwenza avjarja tip A, subtip H5.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/09/2006
Maltese: Data tal-ewwel awtorizzazzjoni: 01.09.2006
English: PHARMACEUTICAL FORM Emulsion for injection
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għal injezzjoni
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda)
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL - 5831 AN Boxmeer.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U L-MANIFATTURA RESPONSABBLI
English: The excipients (including adjuvants) 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: Is-sustanzi mhux attivi (inkluż l-aġġuvanti) imsemmija f'sezzjoni 6.1 tal-KPQ huma jew sustanzi permessi li għalihom tabella tal-anness tar-Regoli tal-Kummisjoni (EU) No 37/2009 jindikaw li l- ebda MRLs mhuma meħtieġa jew huma kunsidrati li ma jaqawx taħt l-iskop tar-Regola (EC) No 470/2009 meta uzati f'dan il-prodott veterinarju medicinali.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 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 tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: INDICATION(S)
Maltese: ATTIVA(I)
English: Excipients: For the full list of excipients see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Intervet International B.V.
English: This product contains mineral oil.
Maltese: Dan il-prodott fih żejt minerali.
English: Future laying hens and breeders: administer a second 0.5 ml dose 4-6 weeks after the first vaccination.
Maltese: Tiġieġ li se jinżammu għall-bajd jew għat-tgħammir: amministra t-tieni 0.5ml doża 4 - 6 ġimgħat wara l-ewwel vaċċinazzjoni.
English: One dose of 0.5 ml contains:
Maltese: Doża ta' 0.5ml fiha:
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Maltese: DOŻA GĦAL KULL SPEĊI, MODI U METODU TA' AMMINISTRAZZJONI
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma' ebda prodott veterinarju mediċinali ieħor.
English: Read the package leaflet before use.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: To the physician:
Maltese: Grupp Farmako-terapewtiku:
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Pack sizes: Cardboard box with 250 or 500 ml multidose glass bottle.
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartuna 250ml / 500ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion for injection
Maltese: VETERINARJU Nobilis Influenza H5N2 emulsjoni għal injezzjoni
English: ANNEX II
Maltese: ANNESS II A.