FrancophonIA/ELRC3.0 huggingface dataset:
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 ttrattati juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattati, inklużi rapporti iżolati).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/03/2012
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride
Maltese: Disodium hydrogen phosphate dihydrate Sodium chloride
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Maltese: *(Valur ċikliku (Ct) ≥ 36 minn metodu validat ta' RT-PCR, li jiindika li m'hemm l-ebda preżenza tal-ġenoma virali).
English: Active substance(s):
Maltese: Sustanza(i) attiva(i):
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Maltese: 20ml (10 dożi) 100ml (50 doża) 240 ml (120 doża)
English: Avoid multiple vial broaching.
Maltese: Evita li tiftaħ kunjetti multipli.
English: Adjuvants: Aluminium hydroxide
Maltese: Aluminium hydroxide
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Bovis suspension for injection for cattle
Maltese: VETERINARJU Zulvac 1+8 Bovis suspensjoni għal injezzjoni għall-ifrat
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Maltese: 100ml (50 doża) 240 ml (120 doża)
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Maltese: Kunjetti tal-polyethylene ta' densità għolja (HDPE) ta' 20, 100 jew 240 mls b'tapp tal-lastiku ta' chlorobutyl elastomer u tapp siġillanti tal-aluminju li jkun fih 10 dożi, 50 jew 120 doża tal-vaċċin.
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: Rue Laid Burniat 1 1348 Louvain-la-Neuve
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: Virus ta' bluetongue inattivat, serotip 8, razza BTV-8/BEL2006/02
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Maltese: Amministra doża waħda ta' 2 ml skont l-iskema ta' tilqim li ġejja: 1 injezzjoni: minn 3 xhur t'età.
English: Per dose of 2 ml:
Maltese: Kull doża ta' 2 ml:
English: Pack of 1 bottle of 10 doses (20 ml).
Maltese: Pakkett ta' flixkun 1 ta' 10 dożi (20 ml).
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Maltese: Zoetis Manufacturing & Research Spain, S.L. Ctra.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per dose of 2 ml:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull doża ta' 2 ml:
English: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Maltese: Virus ta' bluetongue inattivat, serotip 1, razza BTV-1/ALG2006/01 E1 RP* ≥ 1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20ml, 1 x 100ml u 1 x 240 ml
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu ġol-muskolu.
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Maltese: Fi studji tas-sigurtà, reazzjonijiet lokali sa 5 cm fid-dijametru kienu komuni ħafna u reazzjonijiet ta' > 5 cm fid-dijametru kienu komuni wara amministrazzjoni ripetuta ta' doża waħda.
English: Apply usual aseptic procedures.
Maltese: Applika proċeduri asettiċi tas-soltu.
English: A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Maltese: Fi studji tas-sigurtà, żieda temporanja fit-temperatura tar-rektum, li ma teċċedix 2.7°C, kienet komuni waqt it-48 siegħa ta' wara t-tilqima.
English: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02.
Maltese: Virus tal-bluetongue inattivat, serotip 1, razza BTV-1/ALG2006/01 E1 Virus tal-bluetongue inattivat, serotip 8, razza BTV-8/BEL2006/02 Aluminium hydroxide, saponin u thiomersal.
English: Pack sizes
Maltese: ŻMIEN TA' TIŻMIM
English: Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manifattur tas-sustanzi bijoloġiċi attivi Zoetis Manufacturing & Research Spain, S.L.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
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.
English: Zero days.
Maltese: 0 jum
English: Pack of 1 bottle of 120 doses (240 ml).
Maltese: Pakkett ta' flixkun 1 ta' 120 doża (240 ml).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U MANIFATTUR RESPONSABBLI
English: EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
Maltese: EU/2/12/139/003 (240 ml)
English: PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle
Maltese: Zulvac 1+8 Bovis suspensjoni għal injezzjoni għall-ifrat
English: Excipient(s): Thiomersal
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: 2nd injection: 3 weeks after 1st injection.
Maltese: 2 injezzjoni: 3 ġimgħat wara l-1 injezzjoni
English: To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle.
Maltese: Sabiex jistimula l-immunità attiva kontra l-virus ta' bluetongue, serotipi 1 u 8 fl-ifrat.
English: EU/2/12/139/003
Maltese: EU/2/12/139/002 EU/2/12/139/003
English: Name and address of the manufacturer responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Zoetis Manufacturing & Research Spain, S.L.
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, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonali tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, ilbejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Pack of 1 bottle of 50 doses (100 ml).
Maltese: Pakkett ta' flixkun 1 ta' 50 doża (100 ml).
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Maltese: Żieda temporanja fit-temperatura tar-rektum, ta' mhux aktar minn 2°C, tista' sseħħ f'10% tal-annimali matul it-24 siegħa ta' wara l-għoti ta' doża eċċessiva doppja.
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Maltese: Reazzjonijiet lokali ta' < 2 cm fid-dijametru kienu komuni ħafna waqt li reazzjonjiet sa 5 cm fiddijametru kienu komuni fi studji tas-sigurtà wara l-amministrazzjoni ta' doża waħda.
English: Revaccination:
Maltese: Inkompatibilitajiet:
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08.
Maltese: Vaċċini virali inattivati - virus tal-Bluetongue,
English: Adjuvant(s): Aluminium hydroxide
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Aluminium hydroxide
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 20 ml (10 dożi)
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skema dwar tilqim mill-ġdid għandu jiġi miftiehem mal-awtoritajiet kompetenti jew mill-veterinarju responsabbli, filwaqt li titqies is-sitwazzjoni epidemjoloġika lokali.
English: Onset of immunity: 21 days after completion of the primary vaccination course Duration of immunity: 12 months after completion of the primary vaccination course.
Maltese: Bidu tal-immunità: 21 jum wara li tkun saret il-vaċċinazzjoni primarja Tul ta' żmien tal-immunità: 12-il xahar wara li tkun saret il-vaċċinazzjoni primarja
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek dwar kif għandek tarmi mediċini li m'għandekx bżonn.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
Maltese: Tikketta fuq il-kunjett ta' 100 ml jew 240 ml
English: 4.2 Indications for use, specifying the target species For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
Maltese: INDIKAZZJONI(JIET) Għall-immunizzazzjoni attiva għall-ifrat minn 3 xhur għall-prevenzjoni* ta' viremija kkaġunata minn virus tal-bluetongue (BVT), serotipi 1 u 8.
English: Girona
Maltese: IEĦOR
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni
English: RP* ≥ 1
Maltese: NUMR(U/I)
English: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: Zoetis Belgium SA
English: EU/2/12/139/002
Maltese: EU/2/12/139/001 EU/2/12/139/002 EU/2/12/139/003
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali ilvaċċin għandu jintuża biss skont l-istima tal-benefiċċju/riskju tal-veterinarju responsabbli u/jew talAwtoritajiet Kompetenti nazzjonali fuq miżuri kurrenti ta' tilqim kontra l-virus tal-bluetongue (BTV).
English: Camprodón s/n "la Riba" 17813 Vall de Bianya
Maltese: 4.7 Użu fi tqala, fit-treddigħ u fi żmien il-bidien
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Maltese: M'hemmx informazzjoni disponibbli fuq l-użu tal-vaċċin f'annimali seropożittivi inkluż dawk b'antikorpi derivati mill-omm.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used
Maltese: Sabiex tiġi evitata kontaminazzjoni aċċidentali tal-vaċċin waqt l-użu, huwa rrakkomandat li tuża sistema ta' tip ta' injezzjoni multipla meta huwa meħtieġ li jiġu preżentati dożi ogħla.
English: Potassium chloride
Maltese: Potassium chloride Potassium dihydrogen phosphate
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 bijoloġika hija fil-prinċipju ta' nisel bijoloġiku maħsuba biex tipproduċi immunità attiva mhix fi ħdan l-iskop ta' Regolament (KE) Nru 470/2009.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ UNITAJIET ŻGĦAR Tikketta fuq il-kunjett ta' 20 ml
English: DATE OF REVISION OF THE TEXT
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Route of administration
Maltese: Amministrazzjoni
English: • For bromocriptine: Restriction of the maximum dose to 30 mg per day.
Maltese: Restrizzjoni tad-doża massima sa 30 mg kuljum.
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Maltese: - Is-CHMP ikkunsidra r-referenza magħmula skond l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendat, għall-prodotti mediċinali li fihom bromocriptine, cabergoline dihydroergocryptine, lisuride u pergolide.
English: • For bromocriptine and dihydroergocryptine:
Maltese: • Għal bromocriptine u dihydroergocryptine:
English: • For bromocriptine, dihydroergocryptine and lisuride:
Maltese: • Għal bromocriptine, dihydroergocryptine u lisuride:
English: For bromocriptine, dihydroergocryptine and lisuride, an increased risk of fibrosis, including cardiac valvulopathy, cannot be excluded.
Maltese: Għal bromocriptine, dihydroergocryptine u lisuride, riskju miżjud ta' fibrożi, inkluż valvulopatija kardijaka, ma jistax jiġi eskluż.
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline and pergolide, compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Maltese: L-istudju Schade irrapporta proporzjon ta' rata ta' inċidenza (IRR) aġġustata ogħla għal regurġitazzjoni valvulari sintomatika għal cabergoline u pergolide, meta mqabbla ma' bromocriptine, lisuride, u agonisti ta' dopamine mhux derivati minn ergot pramipexole u ropirinole għal liema l-ebda każ ma kien irrapportat.
English: Bromocriptine, dihydroergocryptine and lisuride belong to the class of ergot derived dopamine agonists, which also comprises cabergoline and pergolide.
Maltese: Bromocriptine, dihydroergocryptine u lisuride jappartjenu għall-klassi ta' agonisti ta' dopamine derivati minn ergot, li tinkludi wkoll cabergoline u pergolide.
English: However, cases of valvulopathy were reported for bromocriptine, cabergoline, dihydroergocryptine and pergolide, but not for lisuride.
Maltese: Madankollu, każijiet ta' valvulopatija ġew irrapportati għal bromocriptine, cabergoline, dihydroergocryptine u pergolide, iżda mhux għal lisuride.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Maltese: Is-CHMP irreveda l-informazzjoni kollha magħmula disponibbli mid-detenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq (MAH) dwar ir-riskju ta' fibrożi u valvulopatija minn provi kliniċi, studji osservattivi u rapporti spontanji.
English: For bromocriptine, dihydroergotamine and lisuride, no fibrotic events have been reported by MAHs from clinical trials or observational studies.
Maltese: Għal bromocriptine, dihydroergotamine u lisuride, ebda episodju fibrotiku ma ġie rrapportat millMAHs minn provi kliniċi jew minn studji osservattivi.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Maltese: Fil-21 ta' Ġunju 2007, ir-Renju Unit talab lis-CHMP, skond l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, biex jirrevedi r-riskju ta' fibrożi u valvulopatija kardijaka assoċjati ma' l-użu ta' agonisti ta' dopamine derivati minn ergot, u biex jipprovdi opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti kollha tal-klassi għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: Overall, data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Maltese: B'mod ġenerali, dejta minn rapporti spontanji indikaw li suġġetti li jużaw carbergoline u pergolide huma iktar f'riskju ta' episodji fibrotiċi u valvulopatija milli suġġetti li qegħdin jużaw bromocriptine, lisuride jew dihydroergocryptine.
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Maltese: Fil-laqgħa tiegħu ta' Ġunju 2008, is-CHMP ikkonkluda li l-ammont ta' evidenza fuq ir-riskju ta' episodji fibrotiċi, inklużi valvulopatija, mhuwiex indaqs għall-agonisti kollha ta' dopamine derivati minn ergot.
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for cabergoline and pergolide.
Maltese: Minħabba d-differenzi fil-livell ta' riskju fost agonisti ta' dopamine derivati minn ergot, is-CHMP irrakkomanda li tinħareġ opinjoni separata għal cabergoline u pergolide.
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin Neuropharmacol, 2006).
Maltese: (C.Hofmann et al., Clin Neuropharmacol, 2006).
English: - In view of the available data, the Committee concluded that the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Maltese: - Minħabba d-dejta disponibbli, il-Kumitat ikkonkluda li r-riskju ta' episodji fibrotiċi, inkluż valvulopatija, mhuwiex ugwali għall-agonisti ta' dopamine derivati minn ergot kollha.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Maltese: RAĠUNIJIET GĦALL-EMENDA
English: This warning includes recommendations for the monitoring of patients for signs of fibrosis during treatment.
Maltese: It-twissija tinkludi rakkomandazzjonijiet għallmonitoraġġ ta' pazjenti għal sinjali ta' fibrożi waqt it-trattament.
English: - The CHMP, as a consequence, recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets for the medicinal products containing bromocriptine, dihydroergocryptine and lisuride (see Annex III).
Maltese: - Is-CHMP, bħala konsegwenza, irrakkomanda emendi għas-sezzjonijiet relevanti tas-Sommarju tal-karatteristiċi tal-prodott u tal-Fuljetti ta' tagħrif għall-prodotti mediċinali li fihom bromocriptine, dihydroergocryptine u lisuride (ara l-Anness
English: 13 days.
Maltese: 13-il jum.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
English: • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with
Maltese: • biex jipprevjeni d-dijarea f'irziezet bi storja ta' cryptosporidiosis (infezzjoni bil
English: Halocur can be used:
Maltese: Halocur jista' jintuża:
English: Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse.
Maltese: Sintomi bħal dawn kienu jinkludu d-dijarea, demm fl-ippurgar, tnaqqis fil-konsum tal-ħalib, deidrazzjoni, apatija (tnaqqis fir-rispons), dgħjufija u kollass.
English: The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Maltese: Is-sustanza attiva f'Halocur, halofuginone lactate, ma tħallix lil Cryptosporidium parvum jikber.
English: What is Halocur?
Maltese: X'inhu Halocur?
English: The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B.V. on 29 October 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Halocur valida fl-Unjoni Ewropea kollha lil Intervet International B.V. fid-29 ta' Ottubru 1999.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jinstab fil-modulu 6 ta' dan l-EPAR.
English: • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
Maltese: • biex inaqqas id-dijarea, meta jingħata fl-24 siegħa ta' wara l-bidu tad-dijarea.
English: Why has Halocur been approved?
Maltese: Għaliex ġie approvat Halocur?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni fuq il-bażi tar-rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is the risk associated with Halocur?
Maltese: X'inhu r-riskju assoċjat ma' Halocur?
English: Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa.
Maltese: Halocur ikun fih is-sustanza attiva halofuginone lactate, li tintuża kontra l-mardiet parassitiċi kkawżati mill-protożoa.
English: The marketing authorisation was renewed on 29 October 2004.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fif-29 ta' Ottubru 2004.
English: It was also shown to prevent diarrhoea following 11 days of treatment.
Maltese: Intwera wkoll li jipprevjeni d-dijarea wara 11-il jum ta' trattament.
English: How has Halocur been studied?
Maltese: Kif ġie studjat Halocur?
English: Cryptosporidium), when it is given to newborn calves in the first 24 to 48 hours of life,
Maltese: Cryptosporidium), meta jingħata f'għoġġiela tat-twelid fil-perjodu bejn l-ewwel 24 u 48
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Halocur fil-prevenzjoni u t-tnaqqis tad-dijarea kkawżata minn Cryptosporidium parvum fl-għoġġiela tat-twelid jegħelbu r-riskji tiegħu.
English: Other information about Halocur:
Maltese: Tagħrif ieħor dwar Halocur:
English: This is a parasite belonging to the ‘protozoa' family that invades the digestive system causing diarrhoea.
Maltese: Dan hu parassita li jagħmel parti mill-familja tal‘protożoa' li jinvadi s-sistema diġestiva u jikkawża d-dijarea.
English: In one trial, calves were included from 40 farms.
Maltese: Fi studju minnhom, ħadu sehem għoġġiela minn 40 razzett.
English: If eye irritation persists, medical advice should be sought.
Maltese: Jekk l-irritazzjoni fil-għajn tippersisti, wieħed għandu jitob parir mediku.