FrancophonIA/ELRC3.0 huggingface dataset:
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, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: PACKAGE SIZE 2 single-dose syringes 4 single-dose syringes 10 single-dose syringes
Maltese: 2 siringi b'doża waħda 4 siringi b'doża waħda 10 siringi b'doża waħda
English: DATE OF THE REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għal ġol-muskoli.
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 fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: 4.2 Indications for use, specifying the target species 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 'l 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: RP* 1.0-2.2 * Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Maltese: RP* 1.0 - 2.2 *Qawwa relattiva b'metodu in vitro, imqabbel ma' vaċċin ta' referenza li ntwera li kien effikaċi fiż-żwiemel.
English: Onset of immunity: 3 weeks after primary vaccination course.
Maltese: Bidu tal-immunità: 3 ġimgħat wara l-kors primarju ta' vaċċinazzjoni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
Maltese: EU/2/08/086/005 (4 siringi tal-ħġieġ b'doża waħda)
English: RP* 1.0-2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Maltese: RP* 1.0- 2.2 *Qawwa relattiva b'metodu in vitro, imqabbel ma' vaċċin ta' referenza li ntwera li kien effikaċi fiż-żwiemel.
English: The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Maltese: L-użu ta' Equip WNV inaqqas in-numru ta' żwiemel b'viremija wara infezzjoni naturali, iżda jista' ma jevitahiex b'mod sistematiku.
English: Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains.
Maltese: Tul tal-immunità: 12-il xahar wara l-kors primarju ta' vaċċinazzjoni għal WNV lineage strains 1.
English: • Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
Maltese: • Kors ta' vaċċinazzjoni primarju: l-ewwel injezzjoni minn età ta' sitt xhur, it-tieni injezzjoni 3-5 ġimgħat wara.
English: As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Maltese: Bħala konsegwenza, ma jistax jiġi eskluż li immunodepressjoni temporanja li tista' tkun osservata waqt tqala tista' tinterferixxi mat-teħid talvaċċin.
English: Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva:
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Maltese: IgM-ELISA huwa indikatur qawwi ta' infezzjoni naturali bil-virus West Nile.
English: The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' Equip WNV jista' jkun ipprojbit f'xi Stat Membru fit-territorju kollu tiegħu jew f'parti minnu taħt leġizlazzjoni nazzjonali.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar ilMediċini (http://www.ema.europa.eu/).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses
Maltese: VETERINARJU Equip WNV emulsjoni għal injezzjoni għaż-żwiemel
English: Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Maltese: Ippakkjar: kaxxa ta' 2, 4 jew 10 siringi bil-labar b'doża waħda.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV injection for horses
Maltese: VETERINARJU Equip WNV injezzjoni għaż-żwiemel
English: Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.
Maltese: Agħti l-kontenut kollu tas-siringa (1 ml), permezz ta' injezzjoni fonda ġol-muskoli fin-naħa talgħonq, skont l-iskeda li ġejja:
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Maltese: Република България Zoetis Belgium SA Teл:
English: ADVICE ON CORRECT ADMINISTRATION Not applicable.
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Adjuvant:
Maltese: Inkompatibilitajiet:
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-għoti tal-prodott lill-annimali tinterferixxi mal-implimentazzjoni ta' programm nazzjonali għaddijanjosi, il-kontroll jew l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;
English: No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Maltese: Ma twettqux studji speċifiċi biex jintwera n-nuqqas ta' interferenzi minn antikorpi ġejjin mill-omm fuq it-teħid tal-vaċċin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Maltese: OĦRA 1 ml fih:
English: Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Maltese: Agħti il-kontenut kollu tas-siringa (1 ml), permez ta' injezzjoni fonda ġol-muskoli fil-parti tal-għonq, skond l-iskeda li ġejja:
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Maltese: • Vaċċinazzjoni mill-ġdid: għalkemm din l-iskeda għadha ma ġietx validata kompletament, għandu jintlaħaq grad suffiċjenti ta' protezzjoni wara injezzjoni booster ta' kull sena b'doża waħda ta' 1 ml.
English: Vaccination may interfere with existing sero-epidemiological surveys.
Maltese: Il-vaċċinazzjoni tista' tinterferi ma' studji sero-epidemjoloġiċi eżistenti.
English: It is therefore recommended not to vaccinate foals of less than 6 months of age.
Maltese: Għalhekk huwa rakkomandat li ma jiġi vaċċinat ebda mor ta' età inqas minn 6 xhur.
English: b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
Maltese: b) Il-marda li għaliha l-prodott huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju konċernat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2, 4 or 10 single-dose pre-filled syringes
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 2, 4or 10 siringi tal-polipropilin mimlija bil-lest b'doża waħda.
English: EMA/33181/2010 EMEA/H/C/1201
Maltese: EMA/33181/2010
English: Arepanrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).
Maltese: Arepanrix fih razza tal-influwenza A/California/7/2009 (H1N1) razza li tixbaħ lil v (X-179A).
English: Arepanrix is a vaccine to protect against ‘pandemic' flu.
Maltese: Arepanrix huwa vaċċin li jipproteġi kontra l-influwenza ‘pandemika'.
English: Other information about Arepanrix:
Maltese: Informazzjoni oħra dwar Arepanrix:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arepanrix to GlaxoSmithKline Biologicals s.a. on on 23 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Arepanrix lil GlaxoSmithKline Biologicals s.a. fi 23 ta' Marzu 2010.
English: Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għall-influwenza pandemika (H1N1)v (virion maqsum, mhux attivat, stimulat)
English: This included one study in 4,561 adults, which looked at the ability of Arepanrix H5N1 to trigger the production of antibodies (‘immunogenicity') against this H5N1 strain, and one study comparing it with Pandemrix H5N1.
Maltese: Din kienet tinkludi studju wieħed ta' 4,561 adult, li ħares lejn il-kapaċità ta' Arepanrix H5N1 illi jagħti bidu għall-produzzjoni ta' antikorpi (‘immunoġeniċità') kontra r-razza H5N1, u studju wieħed li qabblu ma' Pandemrix H5N1.
English: This document is a summary of the European Public Assessment Report (EPAR) for Arepanrix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Arepanrix.
English: Arepanrix has been given ‘Conditional Approval'.
Maltese: Arepanrix ingħata ‘Approvazzjoni b'Kundizzjoni'.
English: Arepanrix is very similar to another pandemic vaccine called Pandemrix, which has been available in the European Union (EU) since September 2009.
Maltese: Arepanrix huwa simili ħafna għal vaċċin pandemiku ieħor li jismu Pandemrix, li ilu disponibbli fl-Unjoni Ewropea minn Settembru 2009.
English: The CHMP noted that Arepanrix had already been marketed in Canada and used to vaccinate over 5 million people with no safety concerns.
Maltese: Is-CHMP innota li Arepanrix kien diġà mqiegħed fis-suq fil-Kanada u użat biex jitlaqqmu aktar minn 5 miljun persuna mingħajr ebda tħassib dwar is-sigurtà.
English: The studies of Arepanrix H5N1 showed that the vaccine was able to bring about protective levels of antibodies in at least 70% of people in which it was studied.
Maltese: L-istudji ta' Arepanrix H5N1 urew li l-vaċċin kien kapaċi joħloq livelli ta' protezzjoni tal-antikorpi f'millinqas 70% tan-nies li ġie studjat fuqhom.
English: Arepanrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Maltese: Arepanrix ma għandux jingħata lil nies li kellhom reazzjoni anafilattika (reazzjoni allerġika serja) għal xi wieħed mill-komponenti tal-vaċċin, jew għal xi waħda mis-sustanzi li jinstabu bħala traċċi fil-vaċċin, bħal proteini tal-bajd u tat-tiġieġ, ovalbumin (proteina li tinsab fl-abjad tal-bajd), formaldehyde u sodium deoxycholate.
English: Arepanrix is a vaccine.
Maltese: Arepandrix huwa vaċċin.
English: A further study compared Arepanrix containing the pandemic flu strain H1N1 with Pandemrix H1N1 in 334 adults.
Maltese: Studju ieħor qabbel lil Arepanrix li għandu r-razza tal-influwenza H1N1 ma' Pandemrix H1N1 fi 334 adult.
English: The company that makes Arepanrix will provide data collected in clinical trials of Arepanrix in adults and children, as well as information collected on the safety and effectiveness of the vaccine, to the CHMP for evaluation.
Maltese: Il-kumpanija li tipproduċi Arepanrix sejra tipprovdi dejta miġbura minn provi kliniċi ta' Arepanrix f'adulti u tfal, kif ukoll informazzjoni miġbura dwar is-sigurtà u l-effikaċja tal-vaċċin, lis-CHMP għal evalwazzjoni.
English: The same level of protection was obtained with Arepanrix as with Pandemrix.
Maltese: Inkiseb l-istess livell ta' protezzjoni b'Arepanrix u b'Pandemrix.
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Maltese: Għandu partijiet tal-virusijiet tal-influwenza (flu) li ġew magħmulin inattivati (maqtulin).
English: Why has Arepanrix been approved?
Maltese: Għaliex ġie approvat Arepanrix?
English: What is Arepanrix?
Maltese: X'inhu Arepanrix?
English: The most common side effects with Arepanrix (seen with more than 1 in 10 doses of the vaccine) are headache, joint pain, muscle aches, pain at the site of the injection and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Arepanrix (innutati f'aktar minn doża 1 minn kull 10 tal-vaċċin) huma uġigħ ta' ras, uġigħ fil-ġogi, uġigħ fil-muskoli, uġigħ fis-sit tal-injezzjoni u għejja.
English: This study looked at the immunogenicity against influenza A(H1N1)v.
Maltese: Dan l-istudju ħares lejn limmunoġeniċità kontra l-influwenza A(H1N1)v.
English: Arepanrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Maltese: Arepandrix għandu ammonti żgħar ta' emagglutinini (proteini mill-wiċċ) ta' virus imsemmi A(H1N1)v li qed jikkawża l-pandemija attwali.
English: What information is still awaited for Arepanrix?
Maltese: Liema informazzjoni għadha mistennija għal Arepanrix?
English: What is the risk associated with Arepanrix?
Maltese: X'inhu r-riskju assoċjat ma' Arepanrix?
English: For more information about treatment with Arepanrix, read the Package Leaflet (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar trattament b'Arepanrix, aqra l-Fuljett ta' Tagħrif (parti wkoll mill-EPAR).
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Is-solvent għandu ‘stimulant' (kompost li fih iż-żejt) sabiex itejjeb ir-ripons immunitarju.
English: Which measures are being taken to ensure the safe use of Arepanrix?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Arepanrix?
English: It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Maltese: Għandu jintuża biss għallinfluwenza A (H1N1) influwenza pandemika li ġiet iddikjarata uffiċjalment mill-Organizzazzjoni Dinjija għas-Saħħa fil-11 ta' Ġunju 2009.
English: The study comparing Arepanrix H1N1 with Pandemrix H1N1 showed that one dose was able to trigger immunity to a satisfactory level.
Maltese: L-istudju li jqabbel Arepanrix H1N1 ma' Pandemrix H1N1 wera li doża waħda kienet kapaċi tagħti bidu għall-immunità għal livell sodisfaċenti.
English: The Committee decided that Arepanrix's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Maltese: Il-Kumitat iddeċieda li l-benefiċċji ta' Arepanrix huma akbar mir-riskji għall-profilassi tal-influwenza fis-sitwazzjoni ta' pandemija H1N1 iddikjarata uffiċjalment u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The company that makes Arepanrix will collect information on the safety of the vaccine while it is being used.
Maltese: Il-kumpanija li tipproduċi Arepanrix sejra tiġbor informazzjoni dwar is-sigurtà tal-vaċċin waqt l-użu tiegħu.
English: Both contain the same adjuvant, In Arepanrix, a different method is used to prepare the haemagglutinins used in the vaccine.
Maltese: F'Arepandrix, jintuża metodu differenti sabiex ikunu mħejjija l-emagglutinini użati fil-vaċċin.
English: The company presented information from studies carried out with an earlier version of Arepanrix, containing the ‘bird flu' strain H5N1.
Maltese: Il-kumpanija ppreżentat informazzjoni minn studji li saru b'verżjoni ta' qabel ta' Arepanrix, li kien fiha r-razza H5N1 ta' ‘influwenza tal-għasafar'.
English: How has Arepanrix been studied?
Maltese: Kif ġie studjat Arepanrix?
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-virus bħala 'barrani' u toħloq antikorpi kontrih.
English: For the full list of all side effects reported with Arepanrix, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rraportati b'Arepanrix, ara l-Fuljett ta' Tagħrif.
English: This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Maltese: Dan ikun jinkludi informazzjoni dwar l-effetti sekondarji tiegħu u s-sigurtà tiegħu fit-tfal, lanzjani, nisa tqal, pazjenti b'kundizzjonijiet serji u nies li għandhom problemi bis-sistema immunitarja tagħhom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom day.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Pregabalin Zentiva EMA/351750/2015
Maltese: Pregabalin ZentivaEMA/351750/2015
English: Pregabalin Zentiva is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: Pregabalin Zentiva jiġi bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The maximum dose is 600 mg per
Maltese: Id-doża massima hija ta' 600 mg kuljum.
English: Pregabalin Zentiva is a ‘generic medicine'.
Maltese: Pregabalin Zentiva huwa ‘mediċina ġenerika'.
English: Pregabalin Zentiva pregabalin
Maltese: Informazzjoni oħra dwar Pregabalin Zentiva
English: The full EPAR and risk management plan summary for Pregabalin Zentiva 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: The active substance in Pregabalin Zentiva, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva fi Pregabalin Zentiva, pregabalin, hija simili fl-istruttura għall-aċidu butriku talgamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandha effetti bijoloġiċi differenti ħafna.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pregabalin Zentiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva on 17 July 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pregabalin Zentiva fis-17 ta' Lulju 2015.
English: After three to seven days, the dose can be increased to 300 mg per day.
Maltese: Wara tlieta sa sebat ijiem, id-doża tista' tiżdied għal 300 mg kuljum.
English: Why is Pregabalin Zentiva approved?
Maltese: Għaliex ġie approvat Pregabalin Zentiva?
English: Because Pregabalin Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Maltese: Billi Pregabalin Zentiva huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Lyrica.
English: The recommended starting dose is 150 mg per day, divided into two or three doses.
Maltese: Id-doża rakkomandata inizjali hija ta' 150 mg kuljum, maqsuma f'żewġ dożi jew tlieta.
English: This summary was last updated in July-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Lulju 2015.
English: What are the benefits and risks of Pregabalin Zentiva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pregabalin Zentiva?
English: Because Pregabalin Zentiva 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 Pregabalin Zentiva 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: This means that Pregabalin Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Maltese: Dan ifisser li Pregabalin Zentiva jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Lyrica.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku pregabalin
English: The Committee recommended that Pregabalin Zentiva be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pregabalin Zentiva ikun approvat għall-użu fl-UE.
English: A risk management plan has been developed to ensure that Pregabalin Zentiva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pregabalin Zentiva jintuża bl-aktar mod sigur possibbli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Pregabalin Zentiva għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: How is Pregabalin Zentiva used?
Maltese: Kif jintuża Pregabalin Zentiva?
English: How has Pregabalin Zentiva been studied?
Maltese: Kif ġie studjat Pregabalin Zentiva?
English: Pregabalin Zentiva is a medicine used to treat adults with the following conditions:
Maltese: Pregabalin Zentiva huwa mediċina li tintuża għall-kura ta' adulti bil-kundizzjonijiet li ġejjin:
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Maltese: Dan inaqqas l-attività ta' xi ċelluli tannervituri fil-moħħ u fil-mudullun tas-sinsla tad-dahar, billi jnaqqas ir-rilaxx ta' newrotrażmettituri oħrajn li huma involuti fl-epilessija u l-ansjetà.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem.