FrancophonIA/ELRC3.0 huggingface dataset:
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Maltese: Doża anqas tal-bidu (5 mg/ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara wkoll taqsima 4.4).
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Maltese: EU/1/99/125/001 28 pillola li jinħallu fil-ħalq EU/1/99/125/009 35 pillola li jinħallu fil-ħalq EU/1/99/125/005 56 pillola li jinħallu fil-ħalq EU/1/99/125/013 70 pillola li jinħallu fil-ħalq EU/1/99/125/017 98 pillola li jinħallu fil-ħalq
English: Neuroleptic malignant syndrome (see section
Maltese: .9 Doża eċċessiva Sinjali u sintomi
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Maltese: EU/1/99/125/002 28 pillola li tinħall fil-ħalq EU/1/99/125/010 35 pillola li tinħall fil-ħalq EU/1/99/125/006 56 pillola li tinħall fil-ħalq EU/1/99/125/014 70 pillola li tinħall fil-ħalq
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5 %, respectively).
Maltese: darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Dystonia (including oculogyration) 11
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
Maltese: Kull pillola li tinħall fil-ħalq fiha 10 mg ta' olanzapine
English: Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame,
Maltese: 0.60 mg aspartame
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Maltese: Olanzapine hija indikata għat-trattament ta' l-iskiżofrenja.
English: How to store ZYPREXA VELOTAB
Maltese: X'fiha ZYPREXA VELOTAB
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Maltese: Il-pillola olanzapine li tinħall fil-ħalq hija bioekwivalenti għall-pilloli ta' olanzapine miksija, b'rata u estensjoni ta' l-assorbiment simili.
English: UpCard contains the active substance torasemide.
Maltese: UpCard fih is-sustanza attiva torasemide.
English: The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: EMA/374036/2015 EMEA/V/C/003836
Maltese: EMEA/V/C/003836
English: Torasemide is a diuretic medicine.
Maltese: Torasemide huwa mediċina dijuretika.
English: UpCard EMA/374036/2015
Maltese: EMA/374036/2015
English: UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.
Maltese: UpCard jiġi f'pilloli (0.75 mg, 3 mg, 7.5 mg u 18 mg) u jinkiseb biss b'riċetta ta' tabib.
English: This is a summary of the European public assessment report (EPAR) for UpCard.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal UpCard.
English: Other information about UpCard
Maltese: Informazzjoni oħra dwar UpCard
English: Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Maltese: Indeboliment konġestiv tal-qalb hija kondizzjoni, normalment ta' klieb ikbar fl-età, fejn il-qalb tieqaf tippompja d-demm b'mod effiċjenti madwar il-ġisem u dan iwassal għal sinjali kliniċi bħal intolleranza għall-eżerċizzju (inabilità biex titwettaq attivita fiżika), diffikultà fit-teħid tan-nifs u ritenzjoni ta' fluwidi.
English: In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide.
Maltese: Fi studju prattiku li involva 251 kelb b'indeboliment konġestiv tal-qalb, il-kura b'UpCard tqabblet ma' kura standard bil-furosemide dijuretiku.
English: UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs.
Maltese: UpCard huwa mediċina veterinarja użata għall-kura ta' sinjali ta' indeboliment konġestiv tal-qalb filklieb.
English: The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.
Maltese: L-effetti sekondarji l-aktar komuni b'UpCard huma problemi fil-kliewi u żieda fl-għatx, konsum tal-ilma u mogħdija tal-awrina, li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10.
English: Why is UpCard approved?
Maltese: Għal xiex ġiet approvat UpCard?
English: What are the risks associated with UpCard?
Maltese: X'inhuma r-riskji assoċjati ma' UpCard?
English: People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.
Maltese: Nies b'sensittività eċċessiva magħrufa (allerġija) għal torasemide jew sulfonamides oħrajn għandhom jingħataw il-mediċina b'attenzjoni.
English: This summary was last updated in June 2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ġunju 2015.
English: The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen.
Maltese: Il-kejl ewlieni tal-effikaċja kien ir-rispons għall-kura wara madwar 3 xhur ta' kura, filwaqt li d-diffikultà fit-teħid tan-nifs, il-frekwenza tas-sogħla, l-intolleranza għall-eżerċizzju u r-ritenzjoni tal-fluwidi fl-addome ngħataw punteġġ.
English: For the full list of restrictions and side effects reported with UpCard, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'UpCard, ara l-fuljett ta' tagħrif.
English: The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.
Maltese: L-istudju wera li UpCard huwa għallinqas effettiv daqs furosemide għall-kura ta' sinjali relatati ma' indeboliment konġestiv tal-qalb.
English: Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' UpCard, fosthom il-prekawzjonijiet xierqa li jridu jkunu segwiti mill-professjonisti fil-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: This product may increase urination and gastrointestinal disturbances if ingested.
Maltese: Dan il-prodott jista' jikkawża disturbi fil-mogħdija tal-awrina kif ukoll disturbi gastrointestinali jekk jinbela'.
English: It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Maltese: Jiġi bħala kapsuli bojod (5, 20, 100, 140, 180 u 250 mg).
English: The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Temozolomide Sun is a ‘generic medicine'.
Maltese: Temozolomide Sun huwa ‘mediċina ġenerika'.
English: The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża tat-Temozolomide Sun tiddependi mis-superfiċje tal-ġisem (ikkalkolati mit-tul u l-piż talpazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Sun.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temozolomide Sun.
English: The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temozolomide Sun, temozolomide, tappartjeni għal grupp ta' mediċini ta' kontra lkanċer li jissejħu alkylating agents.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Temozolomide Sun wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Temodal.
English: Temozolomide Sun is a medicine that contains the active substance temozolomide.
Maltese: Temozolomide Sun huwa mediċina li fiha s-sustanza attiva temozolomide.
English: Temozolomide Sun is an anticancer medicine.
Maltese: Temozolomide Sun huwa mediċina kontra l-kanċer.
English: Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Billi Temozolomide Sun huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: What is Temozolomide Sun?
Maltese: Għal xiex jintuża Temozolomide Sun?
English: Because Temozolomide Sun 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 Temozolomide Sun 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: Why has Temozolomide Sun been approved?
Maltese: Għaliex ġie approvat Temozolomide Sun?
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Maltese: Temozolomide Sun jintuża l-ewwel flimkien mar-radjuterapija mbagħad waħdu; adulti u tfal minn tliet snin 'il fuq li jbatu minn glijoma malinja bħalma huma l-glijoblastoma multiforme jew l-astroċitoma anaplastika, meta t-tumur jerġa' jitfaċċa jew isir agħar wara l-kura standard.
English: What are the benefits and risks of Temozolomide Sun?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Temozolomide Sun?
English: This means that Temozolomide Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temozolomide Sun jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Temozolomide Sun valida madwar l-Unjoni Ewropea kollha fit-13 ta' Lulju 2011.
English: How has Temozolomide Sun been studied?
Maltese: Kif ġie studjat Temozolomide Sun?
English: Other information about Temozolomide Sun
Maltese: Kif jintuża Temozolomide Sun?
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Maltese: *Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fin-nagħaġ
English: Packaging Content Package size
Maltese: Kontenut Daqs ta' lIppakkjar
English: The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jipprovdi dejta adegwata u sodisfaċenti li tikkonferma l-bijoekwivalenza tal-prodott tagħhom mal-prodott ta' referenza fi żmien sena mid-deċiżjoni tal-Kummissjoni Ewropea.
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: • The need for effective contraception
Maltese: • Il-ħtiega ta' kontraċettiv effettiv
English: Male patients
Maltese: Pazjenti rġiel
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Maltese: • Assessjar ta' wara t-tqegħid fis-suq u l-konformità (hekk kif japplikaw għal Stat Membru)
English: • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
Maltese: • Ħtieġa ta' prevenzjoni tat-tqala, definizzjoni u l-bżonn ta' metodi kontraċettivi adegwati
English: Confirmation that the physician has discussed the following:
Maltese: Konferma li t-tabib kien iddiskuta dan li ġej:
English: • Neuropathy and adverse reaction reporting forms
Maltese: • Formoli dwar rapport ta' newropatija u episodju avvers
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “Educational Healthcare Professional's Kit” (if applicable to a Member State)
Maltese: • Fuljett tal-professjonisti tal-kura tas-saħħa o Storja ta' thalidomide, sfond dwar Thalidomide Celgene u l- indikazzjoni liċenzjata tagħha o Posoloġija o Perijodu massimu ta' kemm iddum ir-riċetta 4 ġimgħat għal nisa li jistgħu joħorġu tqal 12-il ġimgħa għall-irġiel u għal nisa li ma jistgħux joħorġu tqal o Teratoġeniċità u l-ħtieġa li jiġi evitat l-esponiment tal-fetu o Obbligazzjonijiet tal-professjonisti tal-kura tas-saħħa li biħsiebhom jagħtu bir-riċetta tat-tabib jew jiddistribwixxu Thalidomide Celgene inklużi:
English: Date of counselling
Maltese: Data tas-servizz tal-pariri
English: o Safety Advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy
Maltese: o Avviż dwar is-Sigurtà li jgħodd għall-pazjenti kollha Deskrizzjoni u ġestjoni ta' l-episodji tromboemboliċi u kardjovaskulari u newropatija periferali
English: o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: Healthcare professional booklet Patient booklets Patient cards Summary of Product Characteristics, Package Leaflet and Labelling
Maltese: o Qabel l-għoti bir-riċetta tat-tabib, il-professjonisti kollha tal-kura tas-saħħa li biħsiebhom jagħtu bir-riċetta (u bi qbil ma' l-Awtorità Nazzjonali Kompetenti, jiddistribwixxu) Thalidomide Celgene ser jingħataw Kitt Edukattiv tal-Professjonist fil-Qasam tal-Kura tas-Saħħa li fih dan li ġej: Fuljett tal-professjonisti tal-kura tas-saħħa Fuljetti edukattivi tal-pazjent Kards tal-pazjenti Sommarju tal-Karatteristiċi tal-Prodott, Fuljett ta' Tagħrif u Tikketta
English: • Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results
Maltese: • Kards tal-Pazjent u jew strumenti ekwivalenti: o verifika li ngħata servizz konsultattiv adattat o dokumentazzjoni ta' l-istatus tal-fatt jekk il-pazjenta tistax toħroġ tqila o kaxxa (jew simili) li t-tabib jittikkja biex jikkonfirma li l-pazjent qed juża kontraċettiv effettiv (jekk hi mara li tista' toħroġ tqila) o verifika ta' test inizjali negattiv tat-tqala qabel il-bidu tat-trattament (jekk hi mara li tista' toħroġ tqila) o dati u riżultati tat-test tat-tqala
English: • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Maltese: • Il-ħtieġa li tiġi evitata espożizzjoni lill-fetu
English: • Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment)
Maltese: • Kundizzjonijiet ta' l-ittestjar tat-tqala o Parir dwar testijiet addattati o Frekwenza (qabel ma jibda, kull xahar matul ittrattament u wara t-tmiem tat-trattament)
English: • Treatment initiation forms o There should be 3 types of treatment initiation forms: Female patient of childbearing potential Female patient of non-childbearing potential Male patient o All treatment initiation forms should contain the following elements: Teratogenicity warning
Maltese: • Formoli tal-bidu tat-trattament o Għandu jkun hemm 3 tipi ta' formoli tal-bidu tat-trattament:
English: • Core text as agreed by the CHMP
Maltese: • Formoli tar-rapport inizjali u tar-riżultat tat-tqala
English: • That he should not donate semen during therapy and for one week following discontinuation of thalidomide o Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit”
Maltese: M'għandekx tagħti demm matul it-trattament u għal ġimgħa wara t- tmiem tat-trattament o Algoritma ta' l-implimentazzjoni tal-Pjan tal-Prevenzjoni tat-Tqala Dan ser jgħin fil-kategorizzazzjoni tal-pazjenti, u d-determinazzjoni tal-miżuri meħtieġa għall-prevenzjoni u għat-testijiet tat-tqala.
English: Educational healthcare professional's kit The Educational healthcare professional's kit shall contain the following elements:
Maltese: Kitt edukattiv tal-professjonisti tal-kura tas-saħħa Il-Kitt tal-professjonisti tal-kura tas-saħħa ser ikun fih l-elementi li ġejjin:
English: • Need to avoid foetal exposure
Maltese: • Il-bżonn li jiġi evitat esponiment għall-fetu
English: Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Maltese: Ir-riżultati tat-testijiet ta' l- utent għandhom jingħataw lill-awtorità nazzjonali kompetenti u l-materjal finali għandu jkun validat fil-livell nazzjonali.
English: • That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for female patients with no childbearing potential should also include: Confirmation that the physician has discussed the following:
Maltese: • Li hi għandha tagħti lura l-kapsuli lill-ispiżjar fit-tmiem tat-trattament o Formoli tal-bidu tat-trattament għall-pazjenti nisa li ma jistgħux joħorġu tqal għandhom jinkludu:
English: Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures.
Maltese: L-Istati Membri għandhom jaqblu fuq l-implimentazzjoni lokali tas-sistema tal-kard tal-pazjent.
English: ATCvet code: QI05AA10.
Maltese: QI05AA10
English: Date of last renewal: 12/09/2013
Maltese: Data tal-aħħar tiġdid: 12/09/2013
English: Minimum essential medium (MEM) Phosphate buffered saline
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Minimum essential medium (MEM) Phosphate buffered saline
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttransporta ġo friġġ (2 °C - 8 °C).
English: The vaccine stimulates active immunity against West Nile virus.
Maltese: Il-vaċċin jistimula immunità attiva kontra l-virus West Nile.
English: MARKETING AUTHORISATION NUMBERS EU/2/08/086/004-006
Maltese: EU/2/08/086/004-006
English: Inactivated West Nile virus, strain VM-2
Maltese: Virus West Nile inattivat, razza VM-2
English: SP oil
Maltese: Żejt SP
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 21/11/2008
English: Luxembourg/ Luxemburg Zoetis Belgium SA Tél/Tel.
Maltese: Luxembourg / Luxemburg Zoetis Belgium SA
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated West Nile virus, strain VM-2.
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Virus West Nile inattivat, razza VM-2
English: For WNV lineage 2 strains the duration of immunity has not been established.
Maltese: Għal WNV lineage strains 2 it-tul tal-immunità ma ġietx stabbilita.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: For intramuscular use.
Maltese: Għal użu intramuskulari
English: 4.3 Contraindications
Maltese: KONTRA INDIKAZZJONIJIET
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - 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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn 1 f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' trattament wieħed). - komuni (aktar minn 1 iżda inqas minn 10 annimali f'100 annimal). - mhux komuni (aktar minn 1 iżda inqas minn10 annimali f'1,000 annimal). - rari (aktar minn 1 iżda inqas minn10 annimali f'10,000 annimal). - rari ħafna (inqas minn annimal 1 f'10,000 annimal, inklużi rapporti iżolati).
English: For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Maltese: Għall-immunizzazzjoni attiva ta' żwiemel minn 6 xhur 'il fuq kontra l-marda kkawżata mill-virus West Nile (WNV) billi jitnaqqas in-numru ta' żwiemel b'viremija wara infezzjoni b'WNV lineage strains 1 u 2 u biex jitnaqqas it-tul u s-severità tas-sinjali kliniċi kontra WNV lineage strains 2.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.
Maltese: Immunoloġiċi għal Equidae, vaċċini virali inattivati għaż-zwiemel.