FrancophonIA/ELRC3.0 huggingface dataset:
English: The Federal Institute of Drugs and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint GCP inspection from 9 - 12 March 2015 at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Inspection references: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Maltese: L-Istitut Federali tal-Mediċini u tat-Tagħmir Mediku (BfArM), il-Ġermanja, u l-Ispettorat tal-Kura tasSaħħa (IGZ), il-Ministeru tas-Saħħa tan-Netherlands wettqu spezzjoni konġunta tal-PKT mid-912 ta' Marzu 2015 f'Alkem Laboratories Limited, Dipartiment tal-Bijoekwivalenza, C-17/7, MIDC Industrial Estate, Taloja, Dist.
English: There was one general quality management system implemented at the site which included a quality assurance unit which was responsible for the clinical and the bioanalytical parts of the trial and which reported to the CEO of the facility.
Maltese: Kien hemm sistema tal-ġestjoni tal-kwalità ġenerali waħda implimentata fis-sit li inkludiet unità talassigurazzjoni tal-kwalità li kienet responsabbli għall-partijiet kliniċi u bijoanaltiċi tal-prova u li kienet tirrapporta lis-CEO tal-faċilità.
English: On 8 March 2016 the BfArM initiated a referral under Article 31 of Directive 2001/83/EC, and asked the CHMP to assess the potential impact of the above findings on the benefit-risk balance of marketing authorisation applications and medicinal products authorised on the basis of relevant trials performed at the inspected site between March 2013-March 2015, and issue a recommendation on whether the marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fit-8 ta' Marzu 2016, il-BfArM ta bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE, u talab lis-CHMP sabiex jivvaluta l-impatt potenzjali tas-sejbiet ta' hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju tal-applikazzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq u prodotti mediċinali awtorizzati abbażi tal-provi rilevanti mwettqa fis-sit spezzjonat bejn Marzu 2013Marzu 2015, u joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew revokati.
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
Maltese: • Il-Kumitat irreveda d-dejta u l-informazzjoni kollha disponibbli pprovduta mill-MAHs/mill-applikanti, kif ukoll l-informazzjoni pprovduta minn Alkem Laboratories;
English: Marketing authorisation holders (MAHs) have argued that pharmacovigilance data collected on their medicinal products have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) argumentaw ukoll li d-dejta ta' farmakoviġilanza miġbura dwar il-prodotti mediċinali tagħhom ma indikat l-ebda problema, li setgħet tiġi attribwita għan-nuqqas ta' bijoekwivalenza, bħat-tnaqqis fl-effikaċja jew l-aggravar tas-sigurtà u t tollerabbiltà.
English: The arguments of the MAH were considered, including the results of the studies with the US and Australian originator medicines, the data submitted do not address the requirement to demonstrate bioequivalence vis-à-vis an EU reference medicinal product as required by Article 10 of Directive 2001/83/EC.
Maltese: L-argumenti tal-MAH ġew ikkunsidrati, inkluż ir-riżultati tal-istudji bil-mediċini oriġinatur tal-Istati Uniti u Awstraljani, id-dejta ppreżentata ma tindirizzax ir-rekwiżit li tintwera l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE kif meħtieġ mill-Artikolu 10 tad-Direttiva 2001/83/KE.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Alkem Laboratories Limited during the period between March 2013 and March 2015;
Maltese: • Il-Kumitat ikkunsidra l-proċedura taħt l-Artikolu 31 tad-Direttiva 2001/83/KE għallawtorizzazzjonijiet għat-tqegħid fis-suq u għall-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fissuq għall-prodotti mediċinali li għalihom il-partijiet kliniċi u/jew bijoanalitiċi tal-istudji twettqu f'Alkem Laboratories Limited waqt il-perjodu bejn Marzu 2013 u Marzu 2015;
English: The applicant for the ibuprofen-containing medicinal product affected by the review (Ibuprofen Orion) did not submit alternative data to establish bioequivalence vis-à-vis an EU reference medicinal product.
Maltese: (Ibuprofen Orion) ma ppreżentax dejta alternattiva sabiex jistabbilixxi l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE.
English: Although Alkem agreed to the CAPAs and committed to implement them following the joint GCP inspection in March 2015, the fact that a second inspection in March 2016 by the MHRA identified critical/major findings during the period of concern further demonstrates that the quality management system in place during the period concerned by the procedure was suboptimal.
Maltese: Għalkemm Alkem qablet malCAPAs u obbligat lilha nfisha li timplimentahom wara spezzjoni konġunta tal-PKT f'Marzu 2015, il-fatt li t-tieni spezzjoni f'Marzu 2016 mill-MHRA identifikat sejbiet kritiċi/maġġuri waqt il-perjodu ta' tħassib juri aktar li s-sistema tal-ġestjoni tal-kwalità fis-seħħ waqt il-perjodu kkonċernat mill-proċedura kienet waħda inferjuri.
English: For the riluzole-containing medicinal product affected by the review (Riluzole Alkem), the MAH provided some comparative dissolution data to claim that, as the multi-media dissolution profiles of cefuroxime and riluzole are similar to those of the reference products, the probability of the products being bioequivalent is high.
Maltese: (Riluzole Alkem), il-MAH ipprovda xi dejta ta' dissoluzzjoni komparattiva sabiex isostni li, minħabba li l-profili ta' dissoluzzjoni multimedjali ta' cefuroxime u riluzole huma simili għal dawk tal-prodotti ta' referenza, il-probabbiltà li dawn il-prodotti jkunu bijoekwivalenti hija għolja.
English: A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors.
Maltese: Spezzjoni aktar tard tal-MHRA (Marzu 2016) irriżultat ukoll f'osservazzjoni kritika waħda u fi 2 maġġuri, li għalihom, diġa kien hemm qbil fuq il-CAPAs mal-ispetturi.
English: Intentional misrepresentation of data happened at the site in two different trials performed in 2013 and 2014.
Maltese: Misrappreżentazzjoni intenzjonata tad-dejta seħħet fis-sit f'żewġ provi differenti mwettqa fl-2013 u fl-2014.
English: Therefore BfArM considered that this affects the trustworthiness of the data generated by the site (clinical and bioanalytical) in the time period from the beginning of the first study in March 2013 until the date when the inspection took place in March 2015, as it must be assumed that critical deficiencies could not be detected by the quality management system at the site in the meantime, because corrective actions and preventive actions (CAPAs) were only implemented after the inspection.
Maltese: Għaldaqstant il-BfArM qies li dan jaffettwa l-affidabilità tad-dejta ġġenerata mis-sit (klinika u bijoanalitika) fil-perjodu ta' żmien mill-bidu tal-ewwel studju f'Marzu 2013 sad-data meta twettqet lispezzjoni f'Marzu 2015, minħabba li wieħed irid jassumi li sadanittant nuqqasijiet kritiċi ma setgħux jiġu osservati mis-sistema tal-ġestjoni tal-kwalità fis-sit, minħabba li l-azzjonijiet korrettivi u lazzjonijiet preventivi (CAPAs) ġew implimentati biss wara l-ispezzjoni.
English: In view of the inspection findings and the conclusion that there was a failure of the overall quality management system in place at the site, even of the ECG data for this particular study has no abnormalities, severe failures in other parts of the trial could not be excluded and all the data generated by the site during the period from March 2013 to March 2015 cannot be relied upon.
Maltese: Fid-dawl tas-sejbiet tal-ispezzjoni u l-konklużjoni li kien hemm falliment tas-sistema tal-ġestjoni tal-kwalità ġenerali fis-seħħ fis-sit, anke jekk id-dejta tal-ECG għal dan l-istudju partikolari m'għandhiex anormalitajiet, fallimenti severi f'partijiet oħra tal-prova ma setgħux jiġu esklużi u d-dejta kollha ġġenerata mis-sit waqt il-perjodu minn Marzu 2013 sa Marzu 2015 mhijiex affidabbli.
English: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Maltese: Li jiġu sospiżi l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li għalihom iddejta ta' bijoekwivalenza jew il-ġustifikazzjoni ma kinux ippreżentati jew tqiesu bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE (anness IB), billi d-dettalji li jappoġġjaw l-awtorizzazzjonijiet għat-tqegħid fis suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u r-riskju ta' dawn l-awtorizzazzjonijietgħat-tqegħid fis-suq mhuwiex meqjus favorevoli skont l-Artikolu 116 tad-Direttiva 2001/83/KE.
English: • The Committee concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for:
Maltese: • Il-Kumitat ikkonkluda li d-dettalji li jappoġġjaw l-awtorizzazzjoni għat-tqegħid fis-suq/applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u r-riskju mhuwiex meqjus favorevoli għal:
English: In addition, the MAH presented data to demonstrate that the US and Australian reference medicinal products are similar to the EU reference medicinal product, and that bioequivalence studies comparing the riluzole generic product under discussion to the US and Australian originators concluded in bioequivalence, therefore it is very likely that the product is also bioequivalent to the EU reference medicinal product.
Maltese: Barra minn hekk, il-MAH ippreżenta dejta sabiex juri li l-prodotti mediċinali ta' referenza tal-Istati Uniti u Awstraljani huma simili għall-prodott mediċinali ta' referenza tal-UE, u li l-istudji ta' bijoekwivalenza li jqabblu l-prodott ġeneriku riluzole taħt diskussjoni mal-oriġinaturi tal-Istati Uniti u Awstraljani konklużi f'bijoekwivalenza, għaldaqstant huwa probabbli ħafna li l-prodott huwa bijoekwivalenti wkoll għall-prodott mediċinali ta' referenza tal-UE.
English: The findings of the above mentioned inspection cast doubts on the reliability of the data of bioequivalence studies conducted between 2013 and 2014 at the site inspected.
Maltese: Is-sejbiet tal-ispezzjoni msemmija hawn fuq tefgħu dubji fuq l-affidabilità tad-dejta tal-istudji ta' bijoekwivalenza mwettqa bejn l-2013 u l-2014 fis-sit spezzjonat.
English: The MAH also submitted an expert report with a reassessment of the original bioequivalence study performed by Alkem, concluding that no abnormalities were observed with the ECG data.
Maltese: Il-MAH issottometta wkoll rapport espert b'valutazzjoni mill-ġdid tal-istudju ta' bijoekwivalenza oriġinali mwettaq minn Alkem, fejn ikkonkluda li ma ġewx osservati anormalitajiet bid-dejta tal-ECG.
English: b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
Maltese: L-applikazzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom id-dejta ta' bijoekwivalenza jew il-ġustifikazzjoni ma kinux ippreżentati jew tqiesu bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE (anness IB) ma jissodisfawx il-kriterji għall-awtorizzazzjoni, billi d-dettalji li jappoġġjaw lawtorizzazzjonijiet għat-tqegħid fis-suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u rriskju ta' dawn l-awtorizzazzjonijiet għat-tqegħid fis-suq mhuwiex favorevoli skont l-Artikolu 26 tad-Direttiva 2001/83/KE.
English: 30 HU**
Maltese: 30 UE**
English: (**) Antigen content (VP2 protein) by immuno-assay
Maltese: (**)kontenut tal-Antiġen (proteina VP2) permezz ta' immuno-assay
English: Active substance*:
Maltese: Sustanza attiva*:
English: 100 doses (100 ml)
Maltese: 100 doża (100 ml)
English: (as hydroxide)
Maltese: (bħala hydroxide)
English: Date of first authorisation: 17/12/2010 Date of last renewal: 08/09/2015
Maltese: Data tal-aħħar tiġdid: 08/09/2015
English: 10 doses (10 ml) 50 doses (50 ml)
Maltese: 10 dożi (10 ml) 50 doża (50 ml)
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATC vet code QI04AA02 (sheep) and QI02AA08 (cattle).
Maltese: Grupp Farmako-terapewtiku: vaċċin kontra l-virus tal-Bluetongue, Kodici ATC veterinarja Q104AA02 (nagħaġ) u Q102AA08 (baqar).
English: Store and transport refrigerated (2 ºC - 8 ºC).
Maltese: Aħżen u ttrasporta fil-friġġ (2 ºC - 8 ºC)
English: Haemolytic units
Maltese: Unitajiet emolitiċi
English: 10 doses (10 ml) 50 doses (50 ml) 10 x 50 doses (10 x 50 ml) 100 doses (100 ml) 10 x 100 doses (10 x100 ml)
Maltese: 10 dożi (10 ml) 50 doża (50 ml) 50 dożi (10 x 50 ml) 100 doża (100 ml) 10 x 100 doża (10 x 100 ml)
English: For purification and bottling steps only: MERIAL Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Maltese: Għal miżuri ta'purifikazzjoni u imbottiljar biss: MERIAL Laboratorju ta' Lyon Porte des Alpes Rue de l'Aviation,
English: • Revaccination Annual.
Maltese: • Ripetizzjoni tal-vaċċinazzjoni Annwali.
English: Manufacturer responsible for batch release: MERIAL
Maltese: Manifattur responsabbli biex il-konsenja tmur fis-suq:* MERIAL
English: Suspension for injection
Maltese: Suspensjoni għal injezzjoni
English: For viral culture, inactivation and concentration steps only: MERIAL
Maltese: Għal miżuri ta' kultura virali, inattivazzjoni u konċentrazzjoni biss: MERIAL
English: *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission
Maltese: *(taħt il-livell ta' detection bil-metodu validat RT-PCR ta' 3.68 log10 RNA kopji/ml, li jindika li ma kienx hemm trażmissjoni ta' virus infettiv).
English: The vaccine contains inactivated Bluetongue Virus with aluminium hydroxide and saponin adjuvants.
Maltese: Il-vaċċin fih il-virus inattivat tal-Bluetongue bl-aġġuvanti aluminju hydroxide u saponin.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels Inactivated BTV2 ................................................................................................... ≥ 1.82 log10 pixels Inactivated BTV4 ................................................................................................... ≥ 1.86 log10 pixels Inactivated BTV8 ................................................................................................... ≥ 2.12 log10 pixels (*) maximum of two different inactivated bluetongue virus serotypes.
Maltese: BTV1 inattivat .......................................................................................................... ≥ 1.9 log10 pixels BTV2 inattivat ................................................................................ ≥ 1.82 log10 pixelsBTV4 inattivat
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal li ħadu l-kura) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal li ħadu l-kura) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal li ħadu l-kura inklużi rapporti iżolati).
English: Inactivated Bluetongue Virus ......................................... strain specific pass level (log10 pixels) ** * maximum of two different inactivated bluetongue virus serotypes
Maltese: Virus inattivat tal-Bluetongue ...........................................  strain specific pass level (log10 pixels)** massimu ta' żewġ serotipi tal-virus inattivat tal-Bluetongue (**)Strain-specific pass levels
English: Bottle of 10 and 50 ml
Maltese: Flixkun ta' 10 u 50 ml
English: Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotypes 2 (100 ml, 50 ml and 10 ml bottles) and/or 4 (10 ml bottles): 18 months.
Maltese: Żmien li l-formulazzjoni monovalenti jew bivalenti bis-serotipi 2 tal-virus tal-Bluetongue tista' tinżamm (fliexken ta' 100 ml, 50 ml u 10 ml) u/jew 4 tal-virus tal-Bluetongue tista' tinżamm (fliexken ta' 10 ml ): 18-il xahar
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.
Maltese: Is-sustanzi mhux attivi, (inklużi l-aġġuvanti), elenkati f'sezzjoni 6.1 tal-SPC huma jew sustanzi permessi li għalihom tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Numru 37/2010 tindika li l-ebda MRL mhu meħtieġ.
English: Box of 10 bottles of 100 ml
Maltese: Kaxxa ta' 10 fliexken ta' 100 ml
English: Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotypes 1, 8 (100 ml, 50 ml and 10 ml bottles) and/or 4 (100 ml and 50 ml bottles): 2 years.
Maltese: Żmien li l-formulazzjoni monovalenti jew bivalenti bis-serotipi 1, 8 tal-virus tal-Bluetongue tista' tinżamm (fliexken ta' 100 ml, 50 ml u 10 ml) u/jew 4 tal-virus tal-Bluetongue tista' tinżamm (fliexken ta' 100 ml u 50 ml ): sentejn
English: Adjuvants: Al
Maltese: Al
English: To be supplied only on veterinary prescription.
Maltese: Tħallat ma' ebda prodott mediċinali veterinarju ieħor.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, Stat Membru jista', skont il-leġislazzjoni nazzjonali, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-forniment u/jew l-użu tal-prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva, peress li hija kostitwent ta' oriġini bijoloġika intiża biex tipproduċi immunità attiva, mhix fl-ambitu tar-Regolament (KE) Numru 470/2009.
English: No other adverse reactions except those mentioned in section 4.6 were observed.
Maltese: L-ebda effetti oħra mhux mixtieqa ħlief dawk imsemmija f'sezzjoni 4.6 ma ġew osservati.
English: In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm In very rare cases a transient increase in body temperature, normally not exceeding an average of 1.1 ºC, may occur within 24 hours after vaccination.
Maltese: F'każi rari ħafna jista' jkun hemm żieda temporanja fit-temperatura tal-ġisem, normalment ta' mhux iżjed minn medja ta' 1.1 °C, fi żmien 24 siegħa wara t-tilqim.
English: BTVPUR suspension for injection for sheep and cattle.
Maltese: VETERINARJU BTVPUR, suspensjoni għal injezzjoni għan-nagħaġ u l-baqar.
English: Avoid bubble formation, as this can be irritating at the site of injection.
Maltese: Evita li jiffurmaw bżieżaq, għax dan jista' jkun irritanti fil-post tal-injezzjoni.
English: Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine.
Maltese: Apatija rari ħafna u tranżitorja tista' tiġi osservata wara l-amministrazzjoni ta' doża doppja tal-vaċċin.
English: 1 ml dose*:
Maltese: Kull doża ta' ml fiha*:
English: Not all pack sizes may be marketed Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Maltese: Flixkun tal-polypropylene ta' 50 jew 100 ml b'tapp tal-butyl elastomere Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml) Flixkun tal-ħġieġ tat-Tip I ta' 10 ml b'tapp tal-butyl elastomere Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml)
English: Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml)
Maltese: Kaxxa ta' flixkun ta' 10 dożi (1 x 10 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml) Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml)
English: It induces an active and specific immunity against Bluetongue Virus in the vaccinated animal.
Maltese: Jinduċi immunità attiva u speċifika kontra il-virus tal-bluetongue fl-annimal imlaqqam.
English: A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released
Maltese: Test finali konfermattiv tal-potenza permezz ta' seronewtralizzazzjoni fil-firien jiġi mwettaq meta lott jinħareġ fis-suq
English: Apply usual aseptic procedures.
Maltese: Applika il-proċeduri sterili tas-soltu.
English: Al3+ (as hydroxide) .................................................................................................................. 2.7 mg Saponin ................................................................................................................................... 30 HU** (**)Haemolytic units
Maltese: (bħala hydroxide) ............................................................................................................... 2.7 mg Saponin .................................................................................................................................. 30 UE ** Unitajiet emolitiċi
English: Detailed information of this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).