FrancophonIA/ELRC3.0 huggingface dataset:
English: Updated quality policy of the European Medicines Agency [EMEA/MB/355781/2007/Rev.1] The Management Board adopted the updated quality policy, which, among other changes, incorporates references to the revised internal-control standards, and clarifies the separation of audit and integrated-quality-management advice functions.
Maltese: Politika tal-kwalità aġġornata tal-Aġenzija Ewropea għall-Mediċini [EMEA/MB/355781/2007/Rev.1] Il-Bord ta' Tmexxija adotta l-politika tal-kwalità aġġornata, li, fost bidliet oħra, tinkorpora referenzi għall-istandards riveduti ta' kontroll intern, u tiċċara s-separazzjoni tal-funzjonijiet tal-pariri għall-verifika u għall-ġestjoni tal-kwalità integrata.
English: [EMEA/MB/649766/2008] Summary of transfers of appropriations in the budget, 2008 and 2009.
Maltese: [EMEA/MB/649766/2008] Sommarju tat-trasferimenti tal-approprijazzjonijiet fil-baġit, 2008 u
English: Points for information
Maltese: Punti għall-informazzjoni
English: London, 4-5 March 2009
Maltese: Londra, 4-5 ta' Marzu2009
English: Significant work was carried out in the fields of safety-monitoring of medicines (EudraVigilance, ENCePP projects), communication and transparency, support to innovation, and international activities.
Maltese: Sar xogħol sinifikanti fl-oqsma talmonitoraġġ tas-sigurtà tal-mediċini (proġetti EudraVigilance, ENCePP), tal-komunikazzjoni u t trasparenza, tal-appoġġ għall-innovazzjoni u tal-attivitajiet internazzjonali.
English: Proposal for involvement and participation of patients'/consumers' representatives in the meetings of the CHMP Pharmacovigilance Working Party
Maltese: Proposta għall-involviment u l-parteċipazzjoni tar-rappreżentanti talpazjenti/konsumaturi fil-laqgħat tal-Grupp ta' Ħidma għall-Farmakoviġilanza tasCHMP
English: In February 2009, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion recommending a marketing authorisation under exceptional circumstances for BTVPUR Alsap 8, intended for the active immunisation of sheep and cattle, to prevent viraemia and to reduce clinical signs caused by the bluetongue virus serotype 8.
Maltese: L-ewwel vaċċin ċentralizzat kontra l-marda tal-bluetongue Fi Frar 2009, il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) adotta opinjoni pożittiva li tirrakkomanda awtorizzazzjoni ta' tqegħid fis-suq taħt ċirkostanzi eċċezzjonali għal BTVPUR Alsap 8, li huwa intenzjonat għall-immunizzazzjoni attiva tan-nagħaġ u tal-frat, għallprevenzjoni tal-viremija u biex jitnaqqsu s-sinjali kliniċi kkawżati mill-virus tal-bluetongue serotip 8.
English: [EMEA/MB/20870/2009] Update report on EMEA implementation of the EU telematics strategy.
Maltese: [EMEA/MB/20870/2009] Rapport ta' aġġornament dwar l-implimentazzjoni mill-EMEA talistrateġija tat-Telematika tal-UE.
English: Election of the Management Board Vice-chair [EMEA/MB/81623/2009] The Management Board elected Mrs Lisette Tiddens-Engwirda as Vicechair with the following votes: Sole round - 34 votes Lisette Tiddens-Engwirda
Maltese: Elezzjoni tal-Viċi-president tal-Bord ta' Tmexxija [EMEA/MB/81623/2009] Il-Bord ta' Tmexxija ħatar lis-Sinjura Lisette Tiddens-Engwirda bħala Viċi-president bil-voti li ġejjin: Votazzjoni waħda - 34 vot Lisette Tiddens-Engwirda
English: Some of the deviations of note related to the implementation of the Product Information Management (PIM) and the EU database of clinical trials (EudraCT) projects.
Maltese: Xi wħud mid-devjazzjonijiet importanti kienu relatati mal-implimentazzjoni tal-Ġestjoni talInformazzjoni dwar il-Prodott (Product Information Management - PIM) u mad-database tal-UE talproġetti tal-provi kliniċi (EudraCT).
English: The PDB includes an increase in the establishment plan of 37 posts, with a maximum number of 567 temporary agents.
Maltese: Il-PDB jinkludi żieda fil-pjan ta' stabbiliment ta' 37 kariga, b'numru massimu ta' 567 aġent temporanju.
English: Draft agenda for 4-5 March 2009 meeting [EMEA/MB/663707/2008] The agenda was adopted.
Maltese: Abbozz ta' aġenda għal-laqgħa tal-4-5 ta' Marzu 2009 [EMEA/MB/663707/2008] L-aġenda ġiet adottata.
English: [EMEA/MB/58755/2009] The Management Board also considered the potential financial and budgetary impact of the fee incentives proposed under MUMS/limited markets.
Maltese: [EMEA/MB/58755/2009] Il-Bord ta' Tmexxija kkunsidra wkoll l-impatt finanzjarju u baġitarju potenzjali tal-inċentivi tal-miżati proposti taħt MUMS/swieq limitati.
English: [EMEA/CHMP/89672/2009] The Management Board supported the proposed amendments to the rules of procedure of the CHMP.
Maltese: [EMEA/CHMP/89672/2009] Il-Bord ta' Tmexxija appoġġa l-emendi proposti għar-regoli talproċeduri tas-CHMP.
English: However, the funding of information-technology and telematics projects has a structural issue that will be further affected by future legislation in the field of pharmaceuticals (pharmacovigilance, counterfeit medicines and, possibly, information to patients).
Maltese: Madankollu, l-iffinanzjar ta' proġetti tat-teknoloġija tal-informazzjoni u telematiċi għandu kwistjoni strutturali li sejra tkun affettwata aktar mil-leġiżlazzjoni futura fil-qasam tal-farmaċewtiċi (il-farmakoviġilanza, il-mediċini foloz u, possibbilment, l-informazzjoni għall-pazjenti).
English: Start of the term of office of the Management Board members nominated by the Council [EMEA/MB/87076/2009] The Management Board adopted the decision whereby the term of office of the four members of the Management Board listed in Article 1 of Council Decision No 2009/75/EC commenced on 5 March 2009.
Maltese: Bidu tal-mandat tal-membri tal-Bord ta' Tmexxija nnominati mill-Kunsill [EMEA/MB/87076/2009] Il-Bord ta' Tmexxija adotta d-deċiżjoni li tistabbilixxi li l-mandat tal-erba' membri tal-Bord ta' Tmexxija elenkati fl-Artikolu 1 tad-Deċiżjoni tal-Kunsill Nru 2009/75/KE beda fil-5 ta' Marzu 2009.
English: The public consultation regarding the proposed policy is planned to start in mid June and finish at the end of September 2009.
Maltese: Il-konsultazzjoni pubblika rigward il-politika proposta hija ppjanata li tibda f'nofs Ġunju u tispiċċa fl-aħħar ta' Settembru 2009.
English: As part of the EU-FDA confidentiality arrangements, and of increased collaboration and cooperation between the EMEA and the US Food and Drug Administration (FDA), the two authorities have agreed to exchange staff on a defined-term basis.
Maltese: Bħala parti mill-arranġamenti ta' kunfidenzjalità tal-UE-FDA, u miż-żieda fil-kollaborazzjoni u filkooperazzjoni bejn l-EMEA u l-Amministrazzjoni tal-Ikel u tal-Mediċini tal-Istati Uniti (US Food and Drug Administration - FDA), iż-żewġ awtoritajiet qablu li jiskambjaw xi persunal fuq bażi ta' terminu definit.
English: Minutes from the 61st meeting, 11 December 2008 [EMEA/MB/671250/2008] The Management Board noted the outcome of the written procedure.
Maltese: Minuti mill-61 laqgħa, 11 ta' Diċembru 2008 [EMEA/MB/671250/2008] Il-Bord ta' Tmexxija ħa nota tal-eżitu tal-proċedura bil-miktub.
English: Proxy votes from the representatives of France and Luxembourg were given to Belgium, Malta gave its vote by proxy to Cyprus and the United Kingdom gave its vote by proxy to Denmark.
Maltese: Voti awtorizzati bi prokura ngħataw mir-rappreżentanti ta' Franza u tal-Lussemburgu lill-Belġju, Malta tat il-vot tagħha bi prokura lil Ċipru u r-Renju Unit ta l-vot tiegħu bi prokura lid-Danimarka.
English: Following the entry into force of the proposed additional measures, the cost may rise to an annual figure of €500,000 and, depending on the actual uptake, may even be significantly higher.
Maltese: Wara d-dħul fis-seħħ tal-miżuri addizzjonali proposti, l-ispiża tista' tiżdied għal ċifra annwali ta' €500,000 u, skont it-teħid reali, tista' tkun ħafna ogħla.
English: The members noted the update report from the European Commission on a range of topics, including: the guideline setting out what clinical-trial information should be made available to the public; the pharmaceutical package (legislative proposals on pharmacovigilance, tackling counterfeiting of medicines, and information to patients); the evaluation of the EMEA; a recent meeting with Member State representatives on health-technology assessment; the draft Directive on the application of patients' rights with regard to cross-border healthcare; the Commission communication and proposal on patient safety in Europe; and the launch of a public consultation on the future of Europe's workforce for health.
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kummissjoni Ewropea rigward firxa ta' suġġetti, li jinkludu: il-linja gwida li tistabbilixxi liema informazzjoni dwar provi kliniċi għandha ssir disponibbli għall-pubbliku; il-pakkett farmaċewtiku (proposti leġiżlattivi dwar il-farmakoviġilanza, limmaniġġjar tal-mediċini foloz, u l-informazzjoni lill-pazjenti); l-evalwazzjoni tal-EMEA; laqgħa reċenti ma' rappreżentanti tal-Istati Membri dwar il-valutazzjoni tat-teknoloġija tas-saħħa; l-abbozz tad-Direttiva dwar l-applikazzjoni tad-drittijiet tal-pazjenti fir-rigward tal-kura tas-saħħa transkonfinali; il-komunikazzjoni u l-proposta tal-Kummissjoni dwar is-sigurtà tal-pazjenti fl-Ewropa; u t-tnedija ta' konsultazzjoni pubblika dwar il-futur tal-forza tax-xogħol Ewropea għas-saħħa.
English: The Management Board noted the report from the Heads of Medicines Agencies (HMA), which included: information on the election of Johannes Löwer as the new chair of the HMA management group, replacing Jytte Lyngvig; discussions regarding the EudraPharm database; resources of the network; work on antimicrobial resistance.
Maltese: Il-Bord ta' Tmexxija ħa nota tar-rapport mill-Kapijiet tal-Aġenziji tal-Mediċini (Heads of Medicines Agencies - HMA), li kien jinkludi informazzjoni dwar il-ħatra ta' Johannes Löwer bħala l-president ilġdid tal-grupp ta' tmexxija tal-HMA, minflok Jytte Lyngvig; diskussjonijiet rigward id-database talEudraPharm; riżorsi tan-netwerk; ħidma fuq ir-reżistenza antimikrobjali.
English: Preliminary draft work programme 2010
Maltese: Abbozz ta' programm ta' ħidma preliminari 2010
English: [EMEA/MB/81661/2009] Outcome of written procedures on consultation on changes in the membership of the CHMP and CVMP committees.
Maltese: [EMEA/MB/81661/2009] L-eżitu tal-proċeduri bil-miktub fuq konsultazzjoni dwar bidliet fissħubiji tal-kumitati tal-CHMP u tal-CVMP.
English: [EMEA/118727/2009] The Management Board considered the present state of the discussion on whether the CHMP also has to endorse milestone documents relating to the evaluation of ATMPs.
Maltese: [EMEA/118727/2009] Il-Bord ta' Tmexxija kkunsidra l-istat attwali tad-diskussjoni dwar jekk ilCHMP għandux japprova wkoll dokumenti importanti relatati mal-evalwazzjoni tal-ATMPs.
English: [EMEA/MB/684002/2008] The Management Board heard a presentation on the implementation of the 2008 work programme.
Maltese: [EMEA/MB/684002/2008] Il-Bord ta' Tmexxija sema' preżentazzjoni dwar l-implimentazzjoni talprogramm ta' ħidma tal-2008.
English: Incentives for products for minor uses and minor species or for limited markets
Maltese: Inċentivi għal prodotti ta' użu minuri u speċi minuri jew għal swieq limitati
English: Planning for 2010:
Maltese: Abbozz ta' baġit preliminari 2010
English: The written procedures will include fees for veterinary medicinal products indicated for minor uses and minor species/limited markets, and fees for medicinal products to be used in a health pandemic that affects humans.
Maltese: Il-proċeduri bil-miktub sejrin jinkludu miżati għall-prodotti mediċinali veterinarji li huma indikati għall-użu minuri u speċi minuri/swieq limitati, u miżati għall-prodotti mediċinali għall-użu f'pandemija tas-saħħa li taffettwa lill-bniedem.
English: Presentation ‘Improving the functioning of the EMEA'.
Maltese: Preżentazzjoni ‘It-titjib tal-operat tal-EMEA'.
English: The pilot will commence in April 2009 and will run for three months.
Maltese: Il-proġett pilota sejjer jibda f'April 2009 u sejjer idum tliet xhur.
English: The Agency adopted a record number of positive opinions in the area of initial evaluations.
Maltese: L-Aġenzija adottat numru rekord ta' opinjonijiet pożittivi fil-qasam talevalwazzjonijiet inizjali.
English: The Management Board reiterated the need to find alternative ways of working, including greater use of communication technologies and, possibly, revision of the architecture of the system.
Maltese: Il-Bord ta' Tmexxija reġa' saħaq fuq il-ħtieġa li jinstabu modi alternattivi ta' ħidma, inkluż użu akbar ta' teknoloġiji ta' komunikazzjoni u, possibbilment, reviżjoni tal-arkitettura tas-sistema.
English: [EMEA/103390/2009] The Management Board noted the ongoing discussion between the CHMP and the CAT regarding the CAT rules of procedure and the procedural advice on evaluation of ATMPs.
Maltese: [EMEA/103390/2009] Il-Bord ta' Tmexxija ħa nota tad-diskussjoni li għadha għaddejja bejn il-CHMP u l-CAT rigward ir-regoli tal-proċeduri tal-CAT u l-pariri proċedurali għall-evalwazzjoni tal-ATMPs.
English: Correspondence from Germany and France relating to agenda item 11, specifically the CAT rules of procedure and the procedural advice on evaluation of ATMPs.
Maltese: Korrispondenza mill-Ġermanja u minn Franza relatata mal-entrata tal-aġenda 11, b'mod speċifiku r-regoli ta' proċedura tal-CAT u l-pariri ta' proċedura dwar l-evalwazzjoni tal-ATMPs.
English: The main objectives of the intended new organisation include: integration of the human pre- and postauthorisation (line extensions and variations) procedures; more focus on safety-monitoring of medicines through separation of pharmacovigilance and of risk-management activities from postauthorisation work; creation of a new sector for data management.
Maltese: L-objettivi ewlenin tal-organizzazzjoni l-ġdida maħsuba jinkludu: l-integrazzjoni tal-proċeduri tal-preu post-awtorizzazzjoni għall-bniedem (estensjonijiet tal-linja ta' prodotti u varjazzjonijiet); aktar iffukar fuq il-monitoraġġ tas-sigurtà tal-mediċini permezz tas-separazzjoni tal-attivitajiet talfarmakoviġilanza u tal-ġestjoni tar-riskji mix-xogħol ta' post-awtorizzazzjoni; il-ħolqien ta' settur ġdid għall-ġestjoni tad-dejta.
English: [EMEA/261645/2008] The Management Board endorsed the proposal for a pilot project that aims for greater involvement of patients and consumers in the work of the Agency.
Maltese: [EMEA/261645/2008] Il-Bord ta' Tmexxija approva l-proposta għal proġett pilota li jimmira għal aktar involviment tal-pazjenti u tal-konsumaturi fix-xogħol tal-Aġenzija.
English: Mandate for the Management Board task force on scientific qualification of committee members
Maltese: Mandat tat-task force tal-Bord ta' Tmexxija fuq il-kwalifikazzjoni xjentifika tal-membri tal-kumitat
English: (ATMPs)
Maltese: Ċipru
English: Minutes of the sixty-second meeting of the Management Board
Maltese: Minuti tat-tnejn u sittin laqgħa tal-Bord ta' Tmexxija
English: EMEA annual report 2008
Maltese: Rapport mill-Kummissjoni Ewropea
English: The latter is a new sector with responsibilities for centralising product-information management at the Agency and for improving the interoperability of databases.
Maltese: Dan tal-aħħar huwa settur ġdid b'responsabbiltajiet għaċċentralizzazzjoni tal-ġestjoni tal-informazzjoni dwar il-prodotti fl-Aġenzija u għat-tijib talinteroperabbiltà tad-databases.
English: The proposed budget is subject to a number of risk factors, including: the difficult global economic climate; the entry into force of the revised variations legislation, which may result in a loss of revenue for the Agency and therefore create the need for an increased Community contribution; revision of the remuneration system for rapporteurships; and risks associated with significant fluctuation of exchange rates.
Maltese: Il-baġit propost huwa soġġett għal numru ta' fatturi ta' riskju, inklużi lklima ekonomika dinjija diffiċli; id-dħul fis-seħħ tal-leġiżlazzjoni tal-varjazzjonijiet riveduta, li jista' jirriżulta f'telf ta' dħul għall-Aġenzija u għalhekk joħloq il-ħtieġa għal kontribuzzjoni Komunitarja akbar; ir-reviżjoni tas-sistema ta' remunerazzjoni għar-rappurtar tar-relaturi; u r-riskji assoċjati ma' flutwazzjoni sinifikanti tar-rati ta' skambju.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/193/001-003
Maltese: FIS-SUQ EU/2/15/193/001-003
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/12/2015
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09/12/2015
English: Arginine.
Maltese: Arġinina.
English: 10 syringes.
Maltese: 10 siringi.
English: ATCvet code: QL03AA90
Maltese: QL03AA90
English: Imrestor 15 mg injection pegbovigrastim
Maltese: Imrestor 15 mg injezzjoni pegbovigrastim
English: Store in original packaging.
Maltese: Aħżen fil-pakkett oriġinali.
English: Pegbovigrastim is a modified form of the naturally occurring immunoregulatory cytokine, bovine granulocyte colony stimulating factor (bG-CSF).
Maltese: Pegbovigrastim huwa forma modifikata taċ-ċitokina immunoregulatorja naturali, il-fattur ta' stimulazzjoni tal-kolonja tal-granuloċiti tal-bovini (bG-CSF).
English: 50 syringes.
Maltese: 50 siringa.
English: Arginine hydrochloride.
Maltese: Idroklorur tal-arġinina.
English: In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094).
Maltese: Fi prova Ewropea fuq il-post, l-inċidenza ta' mastite klinika osservata fil-grupp ikkurat kienet ta' 9.1 % (113/1235) u fil-grupp ta' kontroll ta' 12.4 % (152/1230), li turi tnaqqis relattiv fl-inċidenza tal mastite ta' 26.0
English: Available in boxes of 10, 50 or 100 syringes.
Maltese: Disponibbli f'kaxex ta' 10, 50 jew 100 siringa.
English: Pharmacotherapeutic group: Colony stimulating factors.
Maltese: Grupp farmako-terapewtiku: fatturi ta' stimulazzjoni tal-kolonja.
English: Bovine granulocyte colony stimulating factor is a naturally occurring protein produced by mononuclear leukocytes, endothelial cells and fibroblasts.
Maltese: Il-fattur ta' stimulazzjoni tal-kolonja talgranuloċiti tal-bovini huwa proteina naturali prodotta mil-lewkoċiti mononukleari, iċ-ċelluli endoteljali u l-fibroblasti.
English: 100 syringes.
Maltese: 100 siringa.
English: Manufacturer for the batch release: Elanco Speke Operations Fleming Road
Maltese: Manifattur responsabbli għall-ħruġ tal-lott: Elanco Speke Operations Fleming Road
English: STATEMENT OF ACTIVE SUBSTANCES Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull 2.7 ml siringa mimlija għal-lest fiha 15 mg pegbovigrastim.
English: The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Imrestor 15 mg soluzzjoni għall-injezzjoni għall-ifrat hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: A single syringe delivers a dose of 20-40 µg/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 µg/kg bodyweight for a 700 kg cow or 33 µg/kg bodyweight for a 450 kg heifer.
Maltese: Siringa waħda tagħti doża ta' 20-40 µg/kg ta' pegbovigrastim għall-biċċa l-kbira tal-baqar skont il-piż tal-ġisem: eż. doża ta' 21 µg/kg piż tal-ġisem għal baqra ta' 700 kg jew 33 µg/kg ta' piż tal-ġisem għal għoġol ta' 450 kg.
English: Animal species
Maltese: Bovini
English: Or
Maltese: IEĦOR
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: NOT APPLIA BLE
Maltese: MHUX APPLIKA BBLI
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma'prodotti mediċinali oħra jew forom oħra ta' interazzjoni
English: The product may be stored at 25 °C for 24 hours maximum.
Maltese: Il-prodott jista' jinħażen f'temperatura ta' 25 °C għal massimu ta' 24 siegħa.
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) during the course of one treatment) - 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) - 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: PACKAGE SIZE 10 pre-filled syringes 50 pre-filled syringes 100 pre-filled syringes
Maltese: DAQS TAL-PAKKETT 10 siringi mimlijin għal-lest 50 siringa mimlija għal-lest 100 siringa mimlija għal-lest
English: There is no known antidote.
Maltese: M'hemm ebda antidotu magħruf.
English: Biological/ Immunomodulat or
Maltese: immunomodulatur
English: Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1.
Maltese: Pegbovigrastim (Fattur ta' Stimulazzjoni tal-Kolonja tal-Granuloċiti tal-bovini Pegilat [PEG bG-CSF]) 15 mg
English: In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective.
Maltese: Fl-annimali, li għandhom funzjoni immuni mibdula farmaċewtikament eż. dawk li dan l-aħħar irċevew kortikosterojdi mogħtija sistemikament jew mediċini kontra l-infjamazzjoni mhux sterojdi, il-prodott jista' ma jkunx effikaċi.
English: People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal pegbovigrastim għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Pegylated bovine granulocyte colony stimulating factor
Maltese: Klassifikazzjoni terapewtika fattur ta' stimulazzjoni talkolonja tal granuloċiti tal bovini pegilat
English: The immunoregulatory activities of granulocyte colony stimulating factor concerns notably cells of the neutrophilic granulocyte lineage which bear cell surface receptors for the protein.
Maltese: L-attivitajiet immunoregolatorji tal-fattur ta' stimulazzjoni tal-kolonja tal-granuloċiti jikkonċernaw b'mod partikolari ċelluli ta' nisel ta' granuloċiti newtrofiliċi li jkollhom riċetturi fuq wiċċ iċ-ċelluli għall-proteina.
English: In one safety study in Jersey cows the margin of safety of this product was 1.5x the highest recommended dose (an overdose of 60µg/kg was administered on three occasions) (see also section 4.10).
Maltese: Fi studju wieħed dwar is-sigurtà fil-baqar ta' Jersey, il-marġni ta' sigurtà ta' dan il-prodott kienet 1.5 darbiet dik tal-ogħla doża rakkomandata (doża eċċessiva ta' 60 µg/kg ingħatat fi tliet okkażjonijiet) (ara wkoll sezzjoni 4.10).
English: Subcutaneous administration.
Maltese: U METODU TA' AMMINISTRAZZJONI
English: There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticaria and angioedema).
Maltese: Jista' jkun hemm ukoll effetti oħrajn inkluż nawsja u raxx fil-ġilda, reazzjonijiet ta' sensittività eċċessiva (diffikultà biex tieħu n-nifs, pressjoni baxxa, urtikarja u anġjoedema).
English: Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 - 0.35).
Maltese: Abbażi tal-istudji fuq il-post kollha, il-proporzjon ta' mastite pprevenuta permezz tal-kura tal-merħla b'Imrestor (Frazzjoni Pprevenuta) huwa ta' 0.25 (b'intervall ta' kunfidenza ta' 95 % 0.14 - 0.35).