FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 pre-filled syringe without needle guard containing 0.8 ml solution for injection 6 pre-filled syringes without needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle guard containing 0.8 ml solution for injection 6 pre-filled syringes with needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.8 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.8 ml solution for injection
Maltese: 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.8 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.8 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.8 ml ta' soluzzjoni għall-injezzjoni
English: • For patients on peritoneal dialysis Retacrit may be given twice a week.
Maltese: • Għal pazjenti fuq dijalisi peritoneali, Retacrit jista' jingħata darbtejn fil-ġimgħa.
English: 1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection 6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection
Maltese: 6 siringi mimlija minn qabel b'tagħmir ta' tarka għal-labra b'0.6 ml ta' soluzzjoni għall-injezzjoni Siringa 1 mimlija għal-lest b'nassa għal-labra b'0.6 ml ta' soluzzjoni għall-injezzjoni 6 siringi mimlija għal-lest b'nassa għal-labra b'0.6 ml ta' soluzzjoni għall-injezzjoni
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Retacrit is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Maltese: Pazjenti għandhom jiġu mmonitorati mill-qrib sabiex jiġi żgurat li tingħata biss l-anqas doża effettiva approvata ta' Retacrit sabiex ikun hemm kontroll adegwat tal-anemija u tas-sintomi ta' l-anemija filwaqt li l-konċentrazzjoni tal-emoglobina tinżamm taħt jew sa 12 g/dL (7.5 mmol/L).
English: Each pre-filled syringe contains 0.75 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.75ml soluzzjoni.
English: If the haemoglobin concentration has increased <1 g/dL (<0.62 mmol/L) and the reticulocyte count has increased <40 000 cells/µL above baseline, response is unlikely and treatment should be discontinued.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina żdiedet <1 g/dL (<0.62 mmol/L) u l-għadd tarretikoloċiti żdied <40,000 ċelluli/µL 'il fuq mil-linja bażi, ir-rispons huwa dubjuż u t-trattament m'għandux jitkompla.
English: Mean
Maltese: Medda
English: If the haemoglobin concentration has increased by at least 1 g/dL (0.62 mmol/L) or the reticulocyte count has increased ≥ 40 000 cells/µL above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina żdiedet b'minn ta' l-anqas 1 g/dL (0.62 mmol/L) jew lgħadd tar-retikoloċiti żdied ≥ 40,000 ċelluli/µL 'il-fuq mil-linja bażi wara 4 ġimgħat ta' trattament, id-doża għandha tibqa' ta' 150 IU/kg 3 darbiet fil-ġimgħa jew 450 IU/kg darba filġimgħa.
English: 28 patches (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
Maltese: 2mg/24siegħa, 7x 4mg/24siegħa, 7x 6mg/24siegħa, 7x 8mg/24siegħa)
English: Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ ET copolymer/paper)
Maltese: Il-pakkett li jmiss mal-prodott Daqs talpakkett
English: 24 October 2011
Maltese: 24 ta' Ottubru 2011
English: EMA/863769/2011 Rev.1 EMEA/H/A-29/1308
Maltese: EMA/CHMP/582483/2011 Rev.1 EMEA/H/A-29/1308
English: It is available as an oral solution (0.4 mg/ml).
Maltese: Tinstab bħala soluzzjoni orali (0.4 mg/ml).
English: EMA/863769/2011
Maltese: EMA/CHMP/582483/2011
English: What is Dexamethasone Alapis?
Maltese: X'inhu Dexamethasone Alapis?
English: Dexamethasone Alapis is intended for use principally as an anti-inflammatory or immunosuppressant (a medicine that reduces the activity of the immune system) in a range of specific disorders affecting different parts of the body, including the blood, liver, kidney, stomach and gut, muscles, eye, lungs and skin, as well as in certain cancers and in the management of anaphylaxis (severe allergic reaction).
Maltese: Dexamethasone Alapis huwa prinċipalment maħsub għall-użu bħala anti-infjammatorju jew immunosuppressant (mediċina li tnaqqas l-attività tas-sistema immuni) f'firxa ta' disturbi speċifiċi li jaffettwaw lil partijiet differenti tal-ġisem, inkluż id-demm, il-fwied, il-kliewi, l-istonku u l-imsaren, ilmuskoli, l-għajnejn, il-pulmun u l-ġilda, kif ukoll f'ċerti tipi ta' kanċer u fl-immaniġġjar ta' anafilassi (reazzjoni allerġika severa).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Malta) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' Referenza', f'dan il-każ Malta) jivvaluta mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ il-Belġju, il-Bulgarija, Ċipru, il-Ġermanja, il-Greċja, il-Portugall, ir-Rumanija u r-Renju Unit).
English: Dexamethasone Alapis is a medicine that contains the active substance dexamethasone.
Maltese: Dexamethasone Alapis hija mediċina li fiha s-sustanza attiva dexamethasone.
English: Alapis S.A. submitted Dexamethasone Alapis to Malta for a decentralised procedure.
Maltese: Alapis S.A. issottomettiet Dexamethasone Alapis lil Malta għal proċedura deċentralizzata.
English: The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Maltese: Is-sustanza attiva fi Dexamethasone Alapis, dexamethasone, tagħmel parti minn grupp ta' mediċini anti-infjammatorji magħrufa bħala kortikosterojdi.
English: However, the Member States were not able to reach an agreement and the Maltese medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Maltija rriferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-30 ta' Mejju 2011.
English: The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form.
Maltese: Ir-raġunijiet għar-riferiment kienu li l-applikazzjoni, li kienet appoġġata minn letteratura ppubblikata minflok studji li saru bi Dexamethasone Alapis, minħabba li dexamethasone għandu storja ta' użu stabbilit sew fl-UE għal mill-inqas 10 snin, kienet prinċipalment appoġġata minn letteratura li turi s-sigurtà u l-effikaċja ta' dexamethasone fil-forma ta' pillola aktar milli f'forma ta' soluzzjoni orali u d-dejta ta' tqarrib ipprovduta ma kinitx ikkunsidrata xierqa biex tikkonkludi dwar il-profil ta' benefiċċjuriskju tal-forma tas-soluzzjoni orali.
English: Why was Dexamethasone Alapis reviewed?
Maltese: Għaliex ġie rivedut Dexamethasone Alapis?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamethasone Alapis.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Dexamethasone Alapis.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Dexamethasone Alapis outweigh its risks, and the marketing authorisation can be granted in Malta and in the following Member States of the EU: Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Dexamethasone Alapis jegħlbu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata f'Malta u fl-Istati Membri tal-UE li ġejjin: il-Belġju, il-Bulgarija, Ċipru, il-Ġermanja , il-Greċja, ilPortugall, ir-Rumanija u r-Renju Unit.
English: It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling.
Maltese: Taħdem billi tidħol fiċ-ċelloli u timblokka l-produzzjoni ta' fattur ta' tkabbir endotiljali vaskulari (VEGF) u ta' prostaglandini, sustanzi involuti fl-infjammazzjoni u n-nefħa.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted was sufficient to show that Dexamethasone Alapis could be used safely and effectively based on the well established use of dexamethasone.
Maltese: L-awtorità regolatorja tal-mediċini Ġermaniża kienet tal-opinjoni li d-dejta sottomessa biex tappoġġa lapplikazzjoni ma kinitx tipprovdi biżżejjed evidenza biex turi s-sigurtà u l-effikaċja ta' Dexamethasone Alapis.
English: (Invented) name Strength Pharmaceutical Form
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Route of Administration
Maltese: 7 kapsuli
English: Pemetrexed Sandoz is a ‘generic medicine'.
Maltese: Pemetrexed Sandoz huwa ‘mediċina ġenerika'.
English: Pemetrexed Sandoz contains the active substance pemetrexed.
Maltese: Pemetrexed Sandoz fih is-sustanza attiva pemetrexed.
English: Pemetrexed Sandoz is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Sandoz huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers talpulmun:
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Sandoz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Sandoz.
English: The active substance in Pemetrexed Sandoz, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Sandoz, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal‘antimetaboliti'.
English: When Pemetrexed Sandoz is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Sandoz jingħata ma' cisplatin, mediċina ‘antiemetika' (biex tipprevjeni r-remettar) u fluwidi (biex jipprevjenu ddiżidratazzjoni) għandha tingħata wkoll qabel jew wara d-doża ta' cisplatin.
English: Pemetrexed Sandoz pemetrexed
Maltese: Aktar tagħrif ieħor dwar Pemetrexed Sandoz
English: The full EPAR and risk management plan summary for Pemetrexed Sandoz 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 Għal aktar informazzjoni rigward il-kura bi Pemetrexed Sandoz, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew spiżjar tiegħek.
English: Pemetrexed Sandoz is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Pemetrexed Sandoz huwa disponibbli bħala trab li jsir f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: What are the benefits and risks of Pemetrexed Sandoz?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pemetrexed Sandoz?
English: Why is Pemetrexed Sandoz approved?
Maltese: Għaliex ġie approvat Pemetrexed Sandoz?
English: No additional studies were needed as Pemetrexed Sandoz is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Pemetrexed Sandoz huwa mediċina ġenerika li tingħata permezz ta' infużjoni u li fiha l-istess sustanza attiva bħal tal-mediċina ta' referenza, Alimta.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Sandoz.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jirċievu injezzjonijiet ta' vitamina
English: This means that Pemetrexed Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed Sandoz huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta.
English: How is Pemetrexed Sandoz used?
Maltese: Kif jaħdem Pemetrexed Sandoz?
English: Because Pemetrexed Sandoz is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pemetrexed Sandoz huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusin listess bħal dawk tal-mediċina ta' referenza.
English: It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Pemetrexed Sandoz.
English: How has Pemetrexed Sandoz been studied?
Maltese: Kif ġie studjat Pemetrexed Sandoz?
English: Other information about Pemetrexed Sandoz
Maltese: Kif jintuża Pemetrexed Sandoz?
English: A risk management plan has been developed to ensure that Pemetrexed Sandoz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pemetrexed Sandoz jintuża bl-aktar mod sigur possibbli.
English: The NETHERLANDS
Maltese: Olanda
English: Date of last renewal: 16/04/2018
Maltese: Data ta` l-aħħar tiġdid: 16/04/2018
English: ATCvet code: QI05AA10.
Maltese: Kodici ATĊ veterinarja QI05AA10
English: 250 micrograms
Maltese: 250 mikrogrammi
English: 83 micrograms
Maltese: 83 mikrogrammi
English: 42 micrograms
Maltese: 42 mikrogrammi
English: Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Sodjum klorajd Potasjum klorajd Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate
English: Intramuscular use.
Maltese: użu intramuskolari.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2013.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06/06/2013
English: EU/2/13/151/002 (5 pre-filled syringes) EU/2/13/151/003 (10 pre-filled syringes)
Maltese: EU/2/13/151/002 (5 siringi mimlija għall-lest) EU/2/13/151/003 (10 siringi mimlija għall-lest)
English: PACKAGE SIZE 10 vials x 1 dose 5 pre-filled syringes x 1 dose 10 pre-filled syringes x 1 dose
Maltese: 10 kunjetti x 1 doża 5 siringi mimlija għall-lest x 1 doża 10 siringi mimlija għall-lest x 1 doża
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: 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) - 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 vaccine stimulates active immunity against West Nile virus in horses.
Maltese: Il-vaċċin jistimula immunita attiva kontra West Nile vijrus fiż-żwiemel.
English: Iscom-Matrix containing: Purified saponin
Maltese: Iscom-Matrix li fih: Saponin ippurifikat
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C ) Tiffriżax
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile [a clear pictogram of a horse]
Maltese: VETERINARJU Equilis West Nile [pittogramm ċar ta'żiemel]
English: - 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 ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - 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: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001-003
Maltese: EU/2/13/151/001-003
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001 (10 vials)
Maltese: EU/2/13/151/001 (10 kunjetti)
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: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew ikkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Package sizes:
Maltese: Daqs tal-pakett:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA) BIOLOĠIKA ATTIVA(I)
English: 5831 AN Boxmeer
Maltese: NL-5831 AN Boxmeer Olanda
English: Duration of immunity: 12 months.
Maltese: Bidu ta' immunita:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831AN Boxmeer Olanda
English: Inactivated chimeric flavivirus strain YF-WN
Maltese: Strejn inattivat tal- virus kimeriċi Flavivirus
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bioloġika attiva
English: 1 ml vial, 1 ml pre-filled syringe
Maltese: Tiketta 1ml kunjett, 1ml siringa mimlija għall-lest
English: Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża Equilis West Nile għandha lewwel tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrentiperess li dawn l-attivitajiet jistgħu jkunu projbiti fi Stat Membru fuq kull jew parti mit-teritorju tiegħu skond il-leġislazzjoni nazzjonali.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' SKADENZA Jiskadi {xahar/sena}
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
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: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forrniment u/jew l-użu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: Phosphatidylcholine
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Maltese: Kunjett tal ħġieġ tip I ta' 1ml (doża) magħluq b'tapp tal-gomma halogenobutyl u ssiġillat b'kappa talaluminjum.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA <{MM/YYYY}>jew<month YYYY}>… <Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu/.>
English: This swelling normally resolves within 1 to 5 days.
Maltese: Din n-nefħa normalment tinżel fi żmien 1 sa 5 tijiem.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali ttrattati;
English: Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Maltese: Immunizzazzjoni attiva ġħal żwiemel kontra l-virus West Nile (WNV), biex tnaqqas is-sinjali kliniċi tal-marda u l-leżjonijiet fil-moħħ, u sabiex tnaqqas il-viraemia.
English: 1 ml: Inactivated chimeric flavivirus strain YF-WN
Maltese: Strejn inattivat tal- virus kimeriċi flavivirus
English: Horses.
Maltese: Xejn.
English: Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.
Maltese: Vaċċinazzjoni primarja: l-ewwel injezzjoni mill-età ta'6 xhur il-fuq u t-tieni waħda minn 3 sa 5 ġimgħat wara.
English: Adjuvant:
Maltese: Żwiemel
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: L-ENTITÀ LI GĦANDHA L-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: In laboratory studies and field trials:
Maltese: Grupp Farmako-terapewtiku: